Tests olaparib after surgery for pancreatic cancer with a BRCA or PALB2 gene change
Tests olaparib after surgery in adults with pancreatic cancer and a gene change.
Plain-language title generated from the registry record
Registry title: APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Key facts
- Where
- ‘Aiea, ‘Ewa Beach, Aberdeen, Adrian, Albuquerque, Altamonte Springs, Alton, Ames, Anaconda, Anchorage, Ankeny, Ann Arbor, Appleton, Arroyo Grande, Atlanta, Auburn, Aurora, Ballwin, Bardstown, Basking Ridge, Baton Rouge, Bellevue, Bellingham, Bemidji, Bend, Berkeley, Billings, Bismarck, Bloomington, Boise, Bolivar, Boone, Bozeman, Bridgeport, Brighton, Bryan, Bryn Mawr, Buffalo, Burbank, Burien, Camden, Canton, Cape Girardeau, Carbondale, Carmel, Carroll, Carson City, Carterville, Carthage, Celebration, Centerville, Centralia, Chelsea, Chicago, Cincinnati, Clackamas, Clarkston, Clinton, Clive, Coeur d'Alene, Collegeville, Collierville, Colorado Springs, Columbus, Commack, Coon Rapids, Coos Bay, Coral Gables, Corbin, Council Bluffs, Covington, Creston, Crown Point, Dallas, Danville, Dayton, Dearborn, Decatur, Deerfield Beach, Denver, Des Moines, Detroit, Dixon, Duluth, Durango, Dyer, East China Township, Eau Claire, Edmonds, Effingham, Elmhurst, Enumclaw, Eureka, Everett, Exton, Fairbanks, Fairway, Fargo, Farmington, Farmington Hills, Federal Way, Flint, Fort Dodge, Fort Smith, Fort Worth, Franklin, Fremont, Fruitland, Galesburg, Garden City, Gig Harbor, Goldsboro, Grand Island, Great Bend, Great Falls, Green Bay, Greenlawn, Greenville, Grenada, Grosse Pointe Woods, Harrison, Hays, Henderson, Hobart, Honolulu, Hot Springs, Indianapolis, Issaquah, Jacksonville, Janesville, Jefferson, Jefferson City, Johnson Creek, Jonesboro, Joplin, Kalispell, Kansas City, Kearney, Kennewick, Kettering, Kewanee, Kingman, Kissimmee, La Crosse, Lacey, Lake Success, Lakewood, Las Vegas, Lawrence, Lebanon, Lee's Summit, Lexington, Lincoln, Littleton, Livonia, London, Longmont, Longview, Louisville, Macomb, Madison, Marshalltown, Marshfield, Mattoon, Media, Memphis, Meridian, Miami, Middletown, Mineola, Minneapolis, Minocqua, Missoula, Modesto, Monroe, Montvale, Morgantown, Mount Vernon, Mountain View, Mukwonago, Munster, Nampa, Naperville, New Albany, New Lenox, New Orleans, New Richmond, New York, Newberg, North Kansas City, Novi, O'Fallon, Oconomowoc, Oconto Falls, Oklahoma City, Olathe, Omaha, Orange, Oregon City, Orland Park, Orlando, Ottawa, Overland Park, Oxford, Pahrump, Paoli, Papillion, Parker, Parkersburg, Pekin, Peoria, Peru, Philadelphia, Phoenix, Pierre, Pittsburg, Plainfield, Plantation, Pontiac, Portland, Post Falls, Princeton, Pueblo, Puyallup, Redmond, Reno, Renton, Rice Lake, Richardson, Rochester, Rolla, Roseville, Royal Oak, Sacramento, Saginaw, Saint Johnsbury, Saint Joseph, Saint Louis Park, Saint Paul, Sainte Genevieve, Salina, Salt Lake City, San Francisco, San Luis Obispo, San Mateo, Sandpoint, Santa Cruz, Santa Maria, Santa Rosa, Seattle, Sedro-Woolley, Sheboygan, Shelton, Shepherdsville, Silverdale, Sioux Falls, South Bend, Southfield, Southhaven, Spokane, Spokane Valley, Springfield, St Louis, Sterling Heights, Stevens Point, Sturgeon Bay, Sullivan, Sunnyvale, Tacoma, Tawas City, Teaneck, Toledo, Topeka, Troy, Twin Falls, Uniondale, Urbana, Vacaville, Vancouver, Voorhees Township, Walla Walla, Warren, Washington, Washington D.C., Waukee, Waukesha, West Branch, West Des Moines, Weston, Westwood, Williamsville, Winter Park, Wynnewood, Yakima, Yelm, Yorkville, and Ypsilanti, United StatesSee the 453 sites
- Phase
- Phase 2
Where in United States
- Hawaii Cancer Care - Westridge‘Aiea, United StatesTaking people
- Pali Momi Medical Center‘Aiea, United StatesTaking people
- The Queen's Medical Center - West Oahu‘Ewa Beach, United StatesTaking people
- Avera Cancer Institute-AberdeenAberdeen, United StatesTaking people
- Providence Regional Cancer System-AberdeenAberdeen, United StatesNo longer taking part
- Hickman Cancer CenterAdrian, United StatesNo longer taking part
- Presbyterian Kaseman HospitalAlbuquerque, United StatesTaking people
- University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
- AdventHealth AltamonteAltamonte Springs, United StatesTaking people
- OSF Saint Anthony's Health CenterAlton, United StatesNo longer taking part
- Mary Greeley Medical CenterAmes, United StatesTaking people
- McFarland Clinic - AmesAmes, United StatesTaking people
- Community Hospital of AnacondaAnaconda, United StatesTaking people
- Alaska Breast Care and Surgery LLCAnchorage, United StatesNo longer taking part
- Alaska Oncology and Hematology LLCAnchorage, United StatesNo longer taking part
- Alaska Women's Cancer CareAnchorage, United StatesNo longer taking part
- Anchorage Associates in Radiation MedicineAnchorage, United StatesNo longer taking part
- Anchorage Oncology CentreAnchorage, United StatesNo longer taking part
- Anchorage Radiation Therapy CenterAnchorage, United StatesNo longer taking part
- Katmai Oncology GroupAnchorage, United StatesNo longer taking part
- Providence Alaska Medical CenterAnchorage, United StatesNo longer taking part
- UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
- Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesTaking people
- University of Michigan Rogel Cancer CenterAnn Arbor, United StatesTaking people
- ThedaCare Regional Cancer CenterAppleton, United StatesTaking people
- Mission Hope Medical Oncology - Arroyo GrandeArroyo Grande, United StatesNo longer taking part
- PCR OncologyArroyo Grande, United StatesNo longer taking part
- Emory Saint Joseph's HospitalAtlanta, United StatesNo longer taking part
- Emory University Hospital MidtownAtlanta, United StatesNo longer taking part
- Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesNo longer taking part
- MultiCare Auburn Medical CenterAuburn, United StatesNo longer taking part
- Rush-Copley Medical CenterAurora, United StatesNo longer taking part
- Mercy Oncology and Hematology - Clayton-ClarksonBallwin, United StatesTaking people
- CommonSpirit Saint Joseph Hospital - BardstownBardstown, United StatesNo longer taking part
- Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
- Louisiana Hematology Oncology Associates LLCBaton Rouge, United StatesTaking people
- Mary Bird Perkins Cancer CenterBaton Rouge, United StatesTaking people
- Overlake Medical CenterBellevue, United StatesNo longer taking part
- PeaceHealth Saint Joseph Medical CenterBellingham, United StatesNo longer taking part
- Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
- Saint Charles Health SystemBend, United StatesNo longer taking part
- Alta Bates Summit Medical Center-Herrick CampusBerkeley, United StatesTaking people
- Billings Clinic Cancer CenterBillings, United StatesTaking people
- Sanford Bismarck Medical CenterBismarck, United StatesTaking people
- Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
- Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
- Central Care Cancer Center - BolivarBolivar, United StatesNo longer taking part
- McFarland Clinic - BooneBoone, United StatesNo longer taking part
- Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
- United Hospital CenterBridgeport, United StatesTaking people
- Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
- Trinity Health Medical Center - BrightonBrighton, United StatesTaking people
- Saint Joseph Regional Cancer CenterBryan, United StatesNo longer taking part
- Bryn Mawr HospitalBryn Mawr, United StatesNo longer taking part
- Roswell Park Cancer InstituteBuffalo, United StatesTaking people
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbank, United StatesNo longer taking part
- Saint Anne HospitalBurien, United StatesNo longer taking part
- Cooper Hospital University Medical CenterCamden, United StatesTaking people
- Illinois CancerCare-CantonCanton, United StatesTaking people
- Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
- Trinity Health Medical Center - CantonCanton, United StatesTaking people
- Saint Francis Medical CenterCape Girardeau, United StatesTaking people
- Mercy Cancer Center - Cape GirardeauCape Girardeau, United StatesNo longer taking part
- Memorial Hospital of CarbondaleCarbondale, United StatesNo longer taking part
- IU Health North HospitalCarmel, United StatesNo longer taking part
- Saint Anthony Regional HospitalCarroll, United StatesTaking people
- Carson Tahoe Regional Medical CenterCarson City, United StatesNo longer taking part
- SIH Cancer InstituteCarterville, United StatesNo longer taking part
- Illinois CancerCare-CarthageCarthage, United StatesTaking people
- AdventHealth CelebrationCelebration, United StatesNo longer taking part
- Miami Valley Hospital SouthCenterville, United StatesTaking people
- Centralia Oncology ClinicCentralia, United StatesTaking people
- Providence Regional Cancer System-CentraliaCentralia, United StatesNo longer taking part
- Chelsea HospitalChelsea, United StatesTaking people
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
- University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
- University of IllinoisChicago, United StatesTaking people
- Bethesda North HospitalCincinnati, United StatesNo longer taking part
- Good Samaritan Hospital - CincinnatiCincinnati, United StatesNo longer taking part
- TriHealth Cancer Institute-AndersonCincinnati, United StatesNo longer taking part
- TriHealth Cancer Institute-WestsideCincinnati, United StatesNo longer taking part
- Clackamas Radiation Oncology CenterClackamas, United StatesNo longer taking part
- Providence Cancer Institute Clackamas ClinicClackamas, United StatesNo longer taking part
- Hematology Oncology Consultants-ClarkstonClarkston, United StatesTaking people
- Newland Medical Associates-ClarkstonClarkston, United StatesNo longer taking part
- Southeastern Medical Oncology Center-ClintonClinton, United StatesTaking people
- Mercy Cancer Center-West LakesClive, United StatesTaking people
- UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
- Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
- Main Line Health Center-CollegevilleCollegeville, United StatesNo longer taking part
- Baptist Memorial Hospital and Cancer Center-ColliervilleCollierville, United StatesTaking people
- Penrose-Saint Francis HealthcareColorado Springs, United StatesNo longer taking part
- Rocky Mountain Cancer Centers-PenroseColorado Springs, United StatesNo longer taking part
- Baptist Memorial Hospital and Cancer Center-Golden TriangleColumbus, United StatesTaking people
- Memorial Sloan Kettering CommackCommack, United StatesTaking people
- Mercy HospitalCoon Rapids, United StatesTaking people
- Bay Area HospitalCoos Bay, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United StatesTaking people
- Commonwealth Cancer Center-CorbinCorbin, United StatesNo longer taking part
- Alegent Health Mercy HospitalCouncil Bluffs, United StatesNo longer taking part
- Heartland Oncology and Hematology LLPCouncil Bluffs, United StatesNo longer taking part
- Nebraska Cancer Specialists/Oncology Hematology West PC - MEJCouncil Bluffs, United StatesNo longer taking part
- Ochsner Hematology Oncology North Shore - Covington (West Region)Covington, United StatesNo longer taking part
- Greater Regional Medical CenterCreston, United StatesNo longer taking part
- Northwest Cancer Center - Crown PointCrown Point, United StatesTaking people
- Parkland Memorial HospitalDallas, United StatesTaking people
- UT Southwestern Simmons Cancer Center - RedBirdDallas, United StatesTaking people
- UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
- Carle at The RiverfrontDanville, United StatesTaking people
- Miami Valley HospitalDayton, United StatesTaking people
- Miami Valley Hospital NorthDayton, United StatesTaking people
- Premier Blood and Cancer CenterDayton, United StatesTaking people
- Dayton Physician LLC - EnglewoodDayton, United StatesNo longer taking part
- Corewell Health Dearborn HospitalDearborn, United StatesTaking people
- Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
- Decatur Memorial HospitalDecatur, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United StatesTaking people
- AdventHealth PorterDenver, United StatesNo longer taking part
- Broadlawns Medical CenterDes Moines, United StatesTaking people
- Iowa Methodist Medical CenterDes Moines, United StatesTaking people
- Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
- Iowa Lutheran HospitalDes Moines, United StatesNo longer taking part
- Henry Ford Health Saint John HospitalDetroit, United StatesTaking people
- Illinois CancerCare-DixonDixon, United StatesTaking people
- Saint Luke's Hospital of DuluthDuluth, United StatesTaking people
- CommonSpirit Cancer Center MercyDurango, United StatesNo longer taking part
- Mercy Medical CenterDurango, United StatesNo longer taking part
- Northwest Oncology LLCDyer, United StatesTaking people
- Henry Ford River District HospitalEast China Township, United StatesTaking people
- Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
- Swedish Cancer Institute-EdmondsEdmonds, United StatesTaking people
- Carle Physician Group-EffinghamEffingham, United StatesTaking people
- Crossroads Cancer CenterEffingham, United StatesTaking people
- Elmhurst Memorial HospitalElmhurst, United StatesTaking people
- Saint Elizabeth HospitalEnumclaw, United StatesNo longer taking part
- Illinois CancerCare-EurekaEureka, United StatesTaking people
- Providence Regional Cancer PartnershipEverett, United StatesNo longer taking part
- Main Line Health Center-ExtonExton, United StatesNo longer taking part
- Fairbanks Memorial HospitalFairbanks, United StatesNo longer taking part
- University of Kansas Clinical Research CenterFairway, United StatesNo longer taking part
- Sanford Broadway Medical CenterFargo, United StatesTaking people
- Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
- Farmington Health CenterFarmington, United StatesTaking people
- Parkland Health Center - FarmingtonFarmington, United StatesTaking people
- Corewell Health Farmington Hills HospitalFarmington Hills, United StatesNo longer taking part
- Saint Francis HospitalFederal Way, United StatesNo longer taking part
- Cancer Hematology Centers - FlintFlint, United StatesTaking people
- Genesys Hurley Cancer InstituteFlint, United StatesTaking people
- Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
- McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesTaking people
- UI Healthcare Mission Cancer and Blood - Fort DodgeFort Dodge, United StatesTaking people
- Mercy Hospital Fort SmithFort Smith, United StatesNo longer taking part
- UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United StatesTaking people
- Atrium Medical Center-Middletown Regional HospitalFranklin, United StatesTaking people
- Palo Alto Medical Foundation-FremontFremont, United StatesTaking people
- Saint Luke's Cancer Institute - FruitlandFruitland, United StatesTaking people
- Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
- Western Illinois Cancer Treatment CenterGalesburg, United StatesNo longer taking part
- Central Care Cancer Center - Garden CityGarden City, United StatesNo longer taking part
- MultiCare Gig Harbor Medical ParkGig Harbor, United StatesNo longer taking part
- Southeastern Medical Oncology Center-GoldsboroGoldsboro, United StatesTaking people
- Nebraska Cancer Specialists/Oncology Hematology West PCGrand Island, United StatesNo longer taking part
- Central Care Cancer Center - Great BendGreat Bend, United StatesNo longer taking part
- Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
- Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesTaking people
- Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
- Northwell Health Cancer Institute at HuntingtonGreenlawn, United StatesTaking people
- Miami Valley Cancer Care and InfusionGreenville, United StatesTaking people
- Baptist Cancer Center-GrenadaGrenada, United StatesTaking people
- Henry Ford Saint John Hospital - AcademicGrosse Pointe Woods, United StatesTaking people
- Henry Ford Saint John Hospital - Van ElslanderGrosse Pointe Woods, United StatesTaking people
- Memorial Sloan Kettering WestchesterHarrison, United StatesTaking people
- HaysMedHays, United StatesTaking people
- Cancer and Blood Specialists-HendersonHenderson, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - HendersonHenderson, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada-Horizon RidgeHenderson, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada-Southeast HendersonHenderson, United StatesNo longer taking part
- Las Vegas Cancer Center-HendersonHenderson, United StatesNo longer taking part
- Las Vegas Urology - Green ValleyHenderson, United StatesNo longer taking part
- Las Vegas Urology - PebbleHenderson, United StatesNo longer taking part
- Oncology Las Vegas - HendersonHenderson, United StatesNo longer taking part
- Urology Specialists of Nevada - Green ValleyHenderson, United StatesNo longer taking part
- Saint Mary Medical CenterHobart, United StatesTaking people
- Hawaii Cancer Care Inc - Waterfront PlazaHonolulu, United StatesTaking people
- Queen's Cancer Cenrer - POB IHonolulu, United StatesTaking people
- Queen's Cancer Center - KuakiniHonolulu, United StatesTaking people
- Queen's Medical CenterHonolulu, United StatesTaking people
- Straub Clinic and HospitalHonolulu, United StatesTaking people
- CHI Saint Vincent Cancer Center Hot SpringsHot Springs, United StatesNo longer taking part
- Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesNo longer taking part
- Swedish Cancer Institute-IssaquahIssaquah, United StatesTaking people
- Southeastern Medical Oncology Center-JacksonvilleJacksonville, United StatesTaking people
- Mercyhealth Hospital and Cancer Center - JanesvilleJanesville, United StatesTaking people
- McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
- MU Health Care Goldschmidt Cancer CenterJefferson City, United StatesNo longer taking part
- University of Wisconsin Carbone Cancer Center - Johnson CreekJohnson Creek, United StatesTaking people
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboro, United StatesNo longer taking part
- Freeman Health SystemJoplin, United StatesNo longer taking part
- Mercy Hospital JoplinJoplin, United StatesNo longer taking part
- Logan Health Medical CenterKalispell, United StatesTaking people
- Saint Luke's Hospital of Kansas CityKansas City, United StatesTaking people
- University Health Truman Medical CenterKansas City, United StatesTaking people
- University of Kansas Cancer CenterKansas City, United StatesTaking people
- University of Kansas Cancer Center - NorthKansas City, United StatesTaking people
- CHI Health Good SamaritanKearney, United StatesNo longer taking part
- Kadlec Clinic Hematology and OncologyKennewick, United StatesTaking people
- Kettering Medical CenterKettering, United StatesNo longer taking part
- Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
- Kingman Regional Medical CenterKingman, United StatesTaking people
- AdventHealth KissimmeeKissimmee, United StatesNo longer taking part
- Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
- Providence Regional Cancer System-LaceyLacey, United StatesTaking people
- Northwell Health/Center for Advanced MedicineLake Success, United StatesTaking people
- CommonSpirit Saint Anthony Hospital Cancer CenterLakewood, United StatesNo longer taking part
- Saint Clare HospitalLakewood, United StatesNo longer taking part
- OptumCare Cancer Care at CharlestonLas Vegas, United StatesTaking people
- OptumCare Cancer Care at Fort ApacheLas Vegas, United StatesTaking people
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesNo longer taking part
- Ann M Wierman MD LTDLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of NevadaLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - Central ValleyLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - NorthwestLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - Town CenterLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada-SummerlinLas Vegas, United StatesNo longer taking part
- Desert West SurgeryLas Vegas, United StatesNo longer taking part
- Hope Cancer Care of NevadaLas Vegas, United StatesNo longer taking part
- Las Vegas Cancer Center-Medical CenterLas Vegas, United StatesNo longer taking part
- Las Vegas Prostate Cancer CenterLas Vegas, United StatesNo longer taking part
- Las Vegas Urology - Cathedral RockLas Vegas, United StatesNo longer taking part
- Las Vegas Urology - PecosLas Vegas, United StatesNo longer taking part
- Las Vegas Urology - Smoke RanchLas Vegas, United StatesNo longer taking part
- Las Vegas Urology - SunsetLas Vegas, United StatesNo longer taking part
- Oncology Las Vegas - TenayaLas Vegas, United StatesNo longer taking part
- OptumCare Cancer Care at MountainViewLas Vegas, United StatesNo longer taking part
- Radiation Oncology Centers of Nevada CentralLas Vegas, United StatesNo longer taking part
- Radiation Oncology Centers of Nevada SoutheastLas Vegas, United StatesNo longer taking part
- Summerlin Hospital Medical CenterLas Vegas, United StatesNo longer taking part
- Sunrise Hospital and Medical CenterLas Vegas, United StatesNo longer taking part
- University Cancer CenterLas Vegas, United StatesNo longer taking part
- University Medical Center of Southern NevadaLas Vegas, United StatesNo longer taking part
- Urology Specialists of Nevada - CentralLas Vegas, United StatesNo longer taking part
- Urology Specialists of Nevada - NorthwestLas Vegas, United StatesNo longer taking part
- Urology Specialists of Nevada - SouthwestLas Vegas, United StatesNo longer taking part
- Lawrence Memorial HospitalLawrence, United StatesTaking people
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
- Saint Luke's East - Lee's SummitLee's Summit, United StatesTaking people
- University of Kansas Cancer Center - Lee's SummitLee's Summit, United StatesTaking people
- CommonSpirit Saint Joseph Medical Center - East LexingtonLexington, United StatesNo longer taking part
- Saint Joseph Radiation Oncology Resource CenterLexington, United StatesNo longer taking part
- Saint Elizabeth Regional Medical CenterLincoln, United StatesNo longer taking part
- AdventHealth LittletonLittleton, United StatesNo longer taking part
- Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
- CommonSpirit Saint Joseph Hospital LondonLondon, United StatesNo longer taking part
- Longmont United HospitalLongmont, United StatesNo longer taking part
- Rocky Mountain Cancer Centers-LongmontLongmont, United StatesNo longer taking part
- PeaceHealth Saint John Medical CenterLongview, United StatesNo longer taking part
- Jewish HospitalLouisville, United StatesNo longer taking part
- Saints Mary and Elizabeth HospitalLouisville, United StatesNo longer taking part
- UofL Health Medical Center NortheastLouisville, United StatesNo longer taking part
- Henry Ford Saint John Hospital - Macomb MedicalMacomb, United StatesTaking people
- Illinois CancerCare-MacombMacomb, United StatesTaking people
- University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesTaking people
- University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
- McFarland Clinic - MarshalltownMarshalltown, United StatesTaking people
- Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
- Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
- Riddle Memorial HospitalMedia, United StatesTaking people
- Baptist Memorial Hospital and Cancer Center-MemphisMemphis, United StatesTaking people
- Saint Luke's Cancer Institute - MeridianMeridian, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at KendallMiami, United StatesTaking people
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
- Memorial Sloan Kettering MonmouthMiddletown, United StatesTaking people
- NYU Langone Hospital - Long IslandMineola, United StatesTaking people
- Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
- Marshfield Medical Center - MinocquaMinocqua, United StatesTaking people
- Community Medical CenterMissoula, United StatesTaking people
- Saint Patrick Hospital - Community HospitalMissoula, United StatesNo longer taking part
- Memorial Medical CenterModesto, United StatesTaking people
- Toledo Clinic Cancer Centers-MonroeMonroe, United StatesNo longer taking part
- Memorial Sloan Kettering BergenMontvale, United StatesTaking people
- West Virginia University HealthcareMorgantown, United StatesTaking people
- SSM Health Good SamaritanMount Vernon, United StatesNo longer taking part
- Palo Alto Medical Foundation-Gynecologic OncologyMountain View, United StatesNo longer taking part
- ProHealth D N Greenwald CenterMukwonago, United StatesTaking people
- The Community HospitalMunster, United StatesTaking people
- Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
- Saint Luke's Cancer Institute - NampaNampa, United StatesTaking people
- Edward Hospital/Cancer CenterNaperville, United StatesTaking people
- Baptist Memorial Hospital and Cancer Center-Union CountyNew Albany, United StatesTaking people
- UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
- Ochsner Medical Center JeffersonNew Orleans, United StatesNo longer taking part
- Cancer Center of Western WisconsinNew Richmond, United StatesTaking people
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Providence Newberg Medical CenterNewberg, United StatesTaking people
- University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas City, United StatesNo longer taking part
- Henry Ford Health Providence Novi HospitalNovi, United StatesTaking people
- Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
- ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesTaking people
- Saint Vincent Hospital Cancer Center at Oconto FallsOconto Falls, United StatesTaking people
- Mercy Hospital Oklahoma CityOklahoma City, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesNo longer taking part
- The University of Kansas Cancer Center - OlatheOlathe, United StatesTaking people
- Alegent Health Bergan Mercy Medical CenterOmaha, United StatesNo longer taking part
- Alegent Health Immanuel Medical CenterOmaha, United StatesNo longer taking part
- Alegent Health Lakeside HospitalOmaha, United StatesNo longer taking part
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCOmaha, United StatesNo longer taking part
- Nebraska Methodist HospitalOmaha, United StatesNo longer taking part
- Saint Joseph Hospital - OrangeOrange, United StatesTaking people
- Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
- University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesTaking people
- AdventHealth East OrlandoOrlando, United StatesNo longer taking part
- AdventHealth Medical Group Urology at OrlandoOrlando, United StatesNo longer taking part
- Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
- University of Kansas Cancer Center-Overland ParkOverland Park, United StatesTaking people
- University of Kansas Hospital-Indian Creek CampusOverland Park, United StatesTaking people
- Baptist Memorial Hospital and Cancer Center-OxfordOxford, United StatesTaking people
- Hope Cancer Care of Nevada-PahrumpPahrump, United StatesNo longer taking part
- Paoli Memorial HospitalPaoli, United StatesTaking people
- Midlands Community HospitalPapillion, United StatesNo longer taking part
- AdventHealth ParkerParker, United StatesNo longer taking part
- Camden Clark Medical CenterParkersburg, United StatesTaking people
- Illinois CancerCare-PekinPekin, United StatesTaking people
- Illinois CancerCare-PeoriaPeoria, United StatesTaking people
- Methodist Medical Center of IllinoisPeoria, United StatesNo longer taking part
- Illinois CancerCare-PeruPeru, United StatesTaking people
- Valley Radiation OncologyPeru, United StatesNo longer taking part
- University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesTaking people
- Fox Chase Cancer CenterPhiladelphia, United StatesNo longer taking part
- Cancer Center at Saint Joseph'sPhoenix, United StatesNo longer taking part
- Avera Cancer Institute at PierrePierre, United StatesTaking people
- Freeman Physician Group of PittsburgPittsburg, United StatesTaking people
- Mercy Hospital PittsburgPittsburg, United StatesNo longer taking part
- Edward Hospital/Cancer Center?PlainfieldPlainfield, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at PlantationPlantation, United StatesTaking people
- Michigan Healthcare Professionals PontiacPontiac, United StatesTaking people
- Trinity Health IHA Medical Group-Alice Gustafson CenterPontiac, United StatesTaking people
- Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- Providence Portland Medical CenterPortland, United StatesTaking people
- Providence Saint Vincent Medical CenterPortland, United StatesTaking people
- Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
- Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
- Saint Mary Corwin Medical CenterPueblo, United StatesNo longer taking part
- MultiCare Good Samaritan HospitalPuyallup, United StatesNo longer taking part
- Saint Charles Health System-RedmondRedmond, United StatesNo longer taking part
- Radiation Oncology AssociatesReno, United StatesNo longer taking part
- Renown Regional Medical CenterReno, United StatesNo longer taking part
- Saint Mary's Regional Medical CenterReno, United StatesNo longer taking part
- Valley Medical CenterRenton, United StatesTaking people
- Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
- UT Southwestern Clinical Center at Richardson/PlanoRichardson, United StatesTaking people
- Rochester General HospitalRochester, United StatesTaking people
- Unity Park Ridge CampusRochester, United StatesTaking people
- Mayo Clinic in RochesterRochester, United StatesNo longer taking part
- Mercy Clinic-Rolla-Cancer and HematologyRolla, United StatesNo longer taking part
- Phelps Health Delbert Day Cancer InstituteRolla, United StatesNo longer taking part
- Sutter Roseville Medical CenterRoseville, United StatesTaking people
- Corewell Health William Beaumont University HospitalRoyal Oak, United StatesTaking people
- Sutter Medical Center SacramentoSacramento, United StatesTaking people
- MyMichigan Medical Center SaginawSaginaw, United StatesTaking people
- Oncology Hematology Associates of Saginaw Valley PCSaginaw, United StatesNo longer taking part
- Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesTaking people
- Heartland Regional Medical CenterSaint Joseph, United StatesNo longer taking part
- Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
- Regions HospitalSaint Paul, United StatesTaking people
- United HospitalSaint Paul, United StatesTaking people
- Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesTaking people
- Salina Regional Health CenterSalina, United StatesTaking people
- Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
- University of Utah Sugarhouse Health CenterSalt Lake City, United StatesTaking people
- California Pacific Medical Center-Pacific CampusSan Francisco, United StatesTaking people
- Pacific Central Coast Health Center-San Luis ObispoSan Luis Obispo, United StatesNo longer taking part
- Mills Health CenterSan Mateo, United StatesTaking people
- Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
- Palo Alto Medical Foundation-Santa CruzSanta Cruz, United StatesTaking people
- Mission Hope Medical Oncology - Santa MariaSanta Maria, United StatesNo longer taking part
- Providence Medical Foundation - Santa RosaSanta Rosa, United StatesTaking people
- Sutter Pacific Medical FoundationSanta Rosa, United StatesTaking people
- Providence Santa Rosa Memorial HospitalSanta Rosa, United StatesNo longer taking part
- Swedish Medical Center-First HillSeattle, United StatesTaking people
- Pacific Gynecology SpecialistsSeattle, United StatesNo longer taking part
- Swedish Medical Center-Ballard CampusSeattle, United StatesNo longer taking part
- Swedish Medical Center-Cherry HillSeattle, United StatesNo longer taking part
- PeaceHealth United General Medical CenterSedro-Woolley, United StatesNo longer taking part
- Saint Vincent Hospital Cancer Center at SheboyganSheboygan, United StatesTaking people
- Providence Regional Cancer System-SheltonShelton, United StatesNo longer taking part
- Jewish Hospital Medical Center SouthShepherdsville, United StatesNo longer taking part
- Saint Joseph Medical Center Hematology and Oncology - SilverdaleSilverdale, United StatesNo longer taking part
- Avera Cancer InstituteSioux Falls, United StatesTaking people
- Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
- Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
- Memorial Hospital of South BendSouth Bend, United StatesNo longer taking part
- Henry Ford Health Providence Southfield HospitalSouthfield, United StatesTaking people
- Baptist Memorial Hospital and Cancer Center-DesotoSouthhaven, United StatesTaking people
- MultiCare Deaconess Cancer and Blood Specialty Center - DowntownSpokane, United StatesNo longer taking part
- MultiCare Deaconess Cancer and Blood Specialty Center - NorthSpokane, United StatesNo longer taking part
- MultiCare Deaconess Cancer and Blood Specialty Center - ValleySpokane Valley, United StatesNo longer taking part
- Mercy Hospital SpringfieldSpringfield, United StatesTaking people
- Southern Illinois University School of MedicineSpringfield, United StatesTaking people
- Springfield ClinicSpringfield, United StatesTaking people
- Springfield Memorial HospitalSpringfield, United StatesTaking people
- CoxHealth South HospitalSpringfield, United StatesNo longer taking part
- Mercy Hospital Saint LouisSt Louis, United StatesTaking people
- Mercy Hospital SouthSt Louis, United StatesTaking people
- Missouri Baptist Medical CenterSt Louis, United StatesTaking people
- Mercy Infusion Center - ChippewaSt Louis, United StatesNo longer taking part
- Bhadresh Nayak MD PC-Sterling HeightsSterling Heights, United StatesNo longer taking part
- Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
- Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesTaking people
- Missouri Baptist Sullivan HospitalSullivan, United StatesTaking people
- Palo Alto Medical Foundation-SunnyvaleSunnyvale, United StatesTaking people
- Franciscan Research Center-Northwest Medical PlazaTacoma, United StatesNo longer taking part
- MultiCare Tacoma General HospitalTacoma, United StatesNo longer taking part
- MyMichigan Medical Center TawasTawas City, United StatesTaking people
- Holy Name HospitalTeaneck, United StatesNo longer taking part
- Mercy Health - Saint Anne HospitalToledo, United StatesNo longer taking part
- Toledo Clinic Cancer Centers-ToledoToledo, United StatesNo longer taking part
- University of Kansas Health System Saint Francis CampusTopeka, United StatesTaking people
- Corewell Health Beaumont Troy HospitalTroy, United StatesTaking people
- Upper Valley Medical CenterTroy, United StatesTaking people
- Saint Luke's Cancer Institute - Twin FallsTwin Falls, United StatesTaking people
- Memorial Sloan Kettering NassauUniondale, United StatesTaking people
- Carle Cancer CenterUrbana, United StatesTaking people
- The Carle Foundation HospitalUrbana, United StatesNo longer taking part
- Northbay Cancer CenterVacaville, United StatesTaking people
- PeaceHealth Southwest Medical CenterVancouver, United StatesNo longer taking part
- MD Anderson Cancer Center at Cooper-VoorheesVoorhees Township, United StatesTaking people
- Providence Saint Mary Regional Cancer CenterWalla Walla, United StatesNo longer taking part
- Henry Ford Health Warren HospitalWarren, United StatesTaking people
- Henry Ford Warren Hospital - GLCMSWarren, United StatesTaking people
- Illinois CancerCare - WashingtonWashington, United StatesTaking people
- Mercy Hospital WashingtonWashington, United StatesNo longer taking part
- Sibley Memorial HospitalWashington D.C., United StatesTaking people
- UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
- ProHealth Waukesha Memorial HospitalWaukesha, United StatesTaking people
- UW Cancer Center at ProHealth CareWaukesha, United StatesTaking people
- Saint Mary's Oncology/Hematology Associates of West BranchWest Branch, United StatesNo longer taking part
- Mercy Medical Center-West LakesWest Des Moines, United StatesTaking people
- Methodist West HospitalWest Des Moines, United StatesNo longer taking part
- Marshfield Medical Center - WestonWeston, United StatesTaking people
- University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
- Roswell Park Amherst CenterWilliamsville, United StatesTaking people
- AdventHealth Winter ParkWinter Park, United StatesNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesTaking people
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, United StatesNo longer taking part
- Providence Regional Cancer System-YelmYelm, United StatesNo longer taking part
- Rush-Copley Healthcare CenterYorkville, United StatesNo longer taking part
- Huron Gastroenterology PCYpsilanti, United StatesTaking people
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT04858334
- Record updated
- 5 November 2026
- Original description
This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.Read full original descriptionShow less
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
Inclusion: STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA; Patient must be >= 18 years of age on day of consent; Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator; NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling; Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course); Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery); Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org; STEP 1 (RANDOMIZATION) INCLUSION CRITERIA; Patient must have met the eligibility criteria outlined above; Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course); Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports; If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing; Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =< 4 weeks prior to Step 1 randomization; Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy; Patient must be >= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =< 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible; Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities > grade 1 with the exception of alopecia and/or neuropathy); Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment; Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib; Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML; Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib; Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment; Leukocytes >= 3,000/mcL (obtained =< 28 days prior to Step 1 randomization); Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to Step 1 randomization); Platelets >= 100,000/mcL (obtained =< 28 days prior to Step 1 randomization); Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 28 days prior to Step 1 randomization); Total bilirubin =< 1.5 institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =< 2.5 x ULN of the direct bilirubin (obtained =< 28 days prior to Step 1 randomization); Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 28 days prior to Step 1 randomization); Creatinine =< 1.5 institutional ULN OR calculated Cockcroft Gault creatinine clearance > 50 mL/min/1.73 m\^2 (obtained =< 28 days prior to Step 1 randomization); Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load; Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT [QTc] prolongation > 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome; Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited; Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers; Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures; Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent; Patient must have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate; Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery.