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Taking people in United StatesPhase 1

Tests mevrometostat with enzalutamide in men with castration resistant prostate cancer

Tests mevrometostat, alone or with enzalutamide, in men whose prostate cancer kept growing after treatment.

Plain-language title generated from the registry record
Registry title: A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Key facts

Where
Anaheim, Austin, Boston, Dallas, Duarte, Fairfax, Fairway, Hackensack, Irving, Kansas City, Louisville, Myrtle Beach, Nashville, Newton, Norwalk, Oklahoma City, Omaha, Overland Park, Port Angeles, Poulsbo, Rockville, San Antonio, Seattle, Tucson, and Westwood, United StatesSee the 44 sites
Phase
Phase 1

Where in United States

  • Pacific Cancer Medical Center INCAnaheim, United StatesNo longer taking part
  • Texas Oncology-Austin MidtownAustin, United StatesNo longer taking part
  • Brigham and Women's HospitalBoston, United StatesNo longer taking part
  • Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
  • University of Texas Southwestern Medical Center - Simmons Cancer CenterDallas, United StatesNo longer taking part
  • UT Southwestern Medical CenterDallas, United StatesNo longer taking part
  • UT Southwestern University Hospital - William P. Clements, JrDallas, United StatesNo longer taking part
  • UT Southwestern University Hospital - Zale LipshyDallas, United StatesNo longer taking part
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesNo longer taking part
  • City of Hope Investigational Drug Services (IDS)Duarte, United StatesNo longer taking part
  • Virginia Cancer Specialists PCFairfax, United StatesNo longer taking part
  • The University of Kansas - Clinical Research CenterFairway, United StatesNo longer taking part
  • The University of Kansas Cancer Center, Investigational Drug ServicesFairway, United StatesNo longer taking part
  • Hackensack University Medical CenterHackensack, United StatesNo longer taking part
  • John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesNo longer taking part
  • NEXT DallasIrving, United StatesTaking people
  • US Oncology Investigational Product Center (IPC)Irving, United StatesNo longer taking part
  • US Oncology Investigational Products CenterIrving, United StatesNo longer taking part
  • The University of Kansas HospitalKansas City, United StatesNo longer taking part
  • The University of Kansas Medical Center Medical Office BuildingKansas City, United StatesNo longer taking part
  • Norton Cancer Institute, DowntownLouisville, United StatesNo longer taking part
  • Norton Cancer Institute, Norton Healthcare PavilionLouisville, United StatesNo longer taking part
  • Norton HospitalLouisville, United StatesNo longer taking part
  • Carolina Urologic Research CenterMyrtle Beach, United StatesTaking people
  • Parkway Surgery CenterMyrtle Beach, United StatesTaking people
  • Sarah Cannon Research Institute- PharmacyNashville, United StatesTaking people
  • SCRI Oncology PartnersNashville, United StatesTaking people
  • Dana-Farber Cancer Institute - Chestnut HillNewton, United StatesNo longer taking part
  • Norwalk HospitalNorwalk, United StatesNo longer taking part
  • OU Health University of Oklahoma Medical CenterOklahoma City, United StatesTaking people
  • Stephenson Cancer Center (chemo location)Oklahoma City, United StatesTaking people
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, United StatesTaking people
  • The University of Kansas Cancer Center - Indian Creek CampusOverland Park, United StatesNo longer taking part
  • Olympic Medical CenterPort Angeles, United StatesNo longer taking part
  • Fred Hutchinson Cancer Center Alliance PeninsulaPoulsbo, United StatesNo longer taking part
  • Maryland Oncology Hematology, P.A.Rockville, United StatesNo longer taking part
  • NEXT OncologySan Antonio, United StatesTaking people
  • Fred Hutchinson Cancer CenterSeattle, United StatesNo longer taking part
  • University of Washington Medical CenterSeattle, United StatesNo longer taking part
  • Arizona Urology Specialists, PLLCTucson, United StatesNo longer taking part
  • Banner University Medical Center - TucsonTucson, United StatesNo longer taking part
  • The University of Arizona Cancer CenterTucson, United StatesNo longer taking part
  • The University of Arizona Cancer Center-North CampusTucson, United StatesNo longer taking part
  • The University of Kansas Cancer CenterWestwood, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Pfizer
Trial code
NCT03460977EU 2023-509179-18-00
Record updated
15 October 2026
Original description
The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.Read full original descriptionShow less

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.

Part 3, which is open for enrollment is seeking men who:

* have Castration Resistant Prostate Cancer (CRPC) and * have previously received treatment for CRPC and have progressed from the last treatment

All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).

In the assessment phase:

* participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods. * participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and/or itraconazole 1 time a day based on a present schedule. * participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule.

After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.

The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.

Part 1 and Part 2 (Closed for enrollment); Part 3 Key Inclusion Criteria:; Histological or cytological diagnosis of castration resistant prostate cancer; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months; Adequate bone marrow, renal, and liver function; Part 3 Key Exclusion Criteria:; Prior irradiation to >25% of the bone marrow; QTcF interval >480 msec at screening; Hypertension that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy); Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC); Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery; Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4/5 inducers or inhibitors; Prior enzalutamide within the last 4 weeks; DDI SUBSTUDY:; history of CHF or evidence of ventricular dysfunction; fructose intolerance; coadministration of CYP3A4 substrates.

ClinicalTrials.gov NCT03460977 · EU CTIS 2023-509179-18-00