NCT03460977RecruitingPhase 1
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 453 (estimated)
- First submitted
- 12 Feb 2018
- Start date
- 17 Apr 2018
- Primary completion date
- 20 Apr 2028
- Lead sponsor
- Pfizer
- NCT number
- NCT03460977
- EU CT number
- 2023-509179-18-00
- EudraCT number
- 2018-001835-37
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 453
- From 17 Apr 2018 to the primary completion date, 20 Apr 2028
- 87 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (87)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Completed |
| Complex Oncological Center - Plovdiv, EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Complex Oncology Center Ruse EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| Complex Oncology Center Vratsa EOOD Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Completed |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Active, not recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Active, not recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Active, not recruiting |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Active, not recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Active, not recruiting |
| Hospital Quirónsalud Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Consorcio Hospitalario Provincial De Castellon Coordinator of this site? Confirm its status | Castello De La Plana | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Active, not recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Active, not recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Ewha Womans University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Jagiellonskie Centrum Innowacji Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| SBHI of Moscow City Clinical Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Terminated |
| Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department Coordinator of this site? Confirm its status | Moscow | Russia | Terminated |
| LLC "Neyro-klinika" Coordinator of this site? Confirm its status | Moscow | Russia | Active, not recruiting |
| Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary" Coordinator of this site? Confirm its status | Omsk | Russia | Terminated |
| Private Medical Institution "Euromedservice" Coordinator of this site? Confirm its status | Pushkin | Russia | Active, not recruiting |
| Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary" Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Terminated |
| Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Terminated |
| Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N. Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Terminated |
| State Budgetary Healthcare Institution of the Yaroslavl Region Coordinator of this site? Confirm its status | Yaroslavl | Russia | Terminated |
| Pacific Cancer Medical Center INC Coordinator of this site? Confirm its status | Anaheim | United States | Active, not recruiting |
| Texas Oncology-Austin Midtown Coordinator of this site? Confirm its status | Austin | United States | Terminated |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| UT Southwestern University Hospital - Zale Lipshy Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| University of Texas Southwestern Medical Center - Simmons Cancer Center Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| UT Southwestern University Hospital - William P. Clements, Jr Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Coordinator of this site? Confirm its status | Duarte | United States | Active, not recruiting |
| City of Hope Investigational Drug Services (IDS) Coordinator of this site? Confirm its status | Duarte | United States | Active, not recruiting |
| Virginia Cancer Specialists PC Coordinator of this site? Confirm its status | Fairfax | United States | Active, not recruiting |
| The University of Kansas - Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Active, not recruiting |
| The University of Kansas Cancer Center, Investigational Drug Services Coordinator of this site? Confirm its status | Fairway | United States | Active, not recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Active, not recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Active, not recruiting |
| NEXT Dallas Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| US Oncology Investigational Product Center (IPC) Coordinator of this site? Confirm its status | Irving | United States | Terminated |
| US Oncology Investigational Products Center Coordinator of this site? Confirm its status | Irving | United States | Terminated |
| The University of Kansas Medical Center Medical Office Building Coordinator of this site? Confirm its status | Kansas City | United States | Active, not recruiting |
| The University of Kansas Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Active, not recruiting |
| Norton Hospital Coordinator of this site? Confirm its status | Louisville | United States | Active, not recruiting |
| Norton Cancer Institute, Downtown Coordinator of this site? Confirm its status | Louisville | United States | Active, not recruiting |
| Norton Cancer Institute, Norton Healthcare Pavilion Coordinator of this site? Confirm its status | Louisville | United States | Active, not recruiting |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| Parkway Surgery Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Sarah Cannon Research Institute- Pharmacy Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Dana-Farber Cancer Institute - Chestnut Hill Coordinator of this site? Confirm its status | Newton | United States | Active, not recruiting |
| Norwalk Hospital Coordinator of this site? Confirm its status | Norwalk | United States | Active, not recruiting |
| Stephenson Cancer Center (chemo location) Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| OU Health University of Oklahoma Medical Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| The University of Kansas Cancer Center - Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Active, not recruiting |
| Olympic Medical Center Coordinator of this site? Confirm its status | Port Angeles | United States | Active, not recruiting |
| Fred Hutchinson Cancer Center Alliance Peninsula Coordinator of this site? Confirm its status | Poulsbo | United States | Active, not recruiting |
| Maryland Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Rockville | United States | Terminated |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Active, not recruiting |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Active, not recruiting |
| The University of Arizona Cancer Center-North Campus Coordinator of this site? Confirm its status | Tucson | United States | Active, not recruiting |
| Arizona Urology Specialists, PLLC Coordinator of this site? Confirm its status | Tucson | United States | Terminated |
| The University of Arizona Cancer Center Coordinator of this site? Confirm its status | Tucson | United States | Active, not recruiting |
| Banner University Medical Center - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Active, not recruiting |
| The University of Kansas Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.