A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
NCT ID: NCT03460977
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
433 participants
INTERVENTIONAL
2018-04-17
2029-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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 will take mevrometostat 2 times a day, with or without 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 studywill look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose Escalation (Part 1A)
Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
Mervometostat (PF-06821497)
Oral continuous
Dose Escalation (Part 1B)
Participants with FL will receive mevrometostat at escalating dose levels
Mervometostat (PF-06821497)
Oral continuous
Dose Escalation (Part 1C)
Participants with mCRPC will receive PF-06821497 at escalating dose levels.
Mervometostat (PF-06821497)
Oral continuous
Dose Escalation (Part 2A)
Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
Dose Expansion (Part 2B)
Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
Japan Cohort
Participants with CRPC will receive mevrometostat at one or two doses
Mervometostat (PF-06821497)
Oral continuous
China cohort
Participants will receive mevrometostat at one or two doses
Mervometostat (PF-06821497)
Oral continuous
Dose Expansion (Part 2C)
Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
BE Substudy
In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
DDI Substudy
In the assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner-University Medical Center Tucson
Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States
Pacific Cancer Medical Center INC
Anaheim, California, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky, United States
Norton Cancer Institute Pharmacy
Louisville, Kentucky, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, United States
Tennessee Oncology PLLC
Franklin, Tennessee, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States
Tenessee Oncology, PLLC
Hendersonville, Tennessee, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States
Tennessee Oncology PLLC
Murfreesboro, Tennessee, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
Tennessee Oncolgy, PLLC
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology-PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center
Irving, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Olympic Medical Center
Port Angeles, Washington, United States
Fred Hutchinson Cancer Center Alliance Peninsula
Poulsbo, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, , Bulgaria
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, , Poland
Centrum Diagnostyczne Affidea Koszalin
Koszalin, , Poland
Centrum Medyczne MEDYK
Rzeszów, , Poland
LUX MED Onkologia Sp. z o.o. Szpital Szamocka
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, , Poland
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, Russia
LLC "Neyro-klinika"
Moscow, , Russia
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
Moscow, , Russia
SBHI of Moscow City Clinical Hospital
Moscow, , Russia
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
Omsk, , Russia
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
Saint Petersburg, , Russia
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
Saint Petersburg, , Russia
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
Saint Petersburg, , Russia
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Saint Petersburg, , Russia
State Budgetary Healthcare Institution of the Yaroslavl Region
Yaroslavl, , Russia
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Chungnam national university hospital
Daejeon, Taejǒn-kwangyǒkshi, South Korea
Institut Català d´Oncología (ICO)-H. Durán i Reynals
L'Hospitalet de Llobregat, Barecelona, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon, Spain
Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Quironsalud Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
H.U. Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
START Madrid CIOCC - HM Sanchinarro Hospital
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EZH2
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509179-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C2321001
Identifier Type: -
Identifier Source: org_study_id