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)
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- Small Cell Lung Cancer (SCLC)
- Follicular Lymphoma (FL)
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 453
- Started
- 17 April 2018
- Main results due
- 20 April 2028
- Study sites
- 85
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(85)
Banner-University Medical Center Tucson
Tucson, Arizona, United States
Active, not recruiting
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Active, not recruiting
The University of Arizona Cancer Center
Tucson, Arizona, United States
Active, not recruiting
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States
Terminated
Pacific Cancer Medical Center INC
Anaheim, California, United States
Active, not recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Active, not recruiting
City of Hope Investigational Drug Services (IDS)
Duarte, California, United States
Active, not recruiting
Norwalk Hospital
Norwalk, Connecticut, United States
Active, not recruiting
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, United States
Active, not recruiting
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
Active, not recruiting
The University of Kansas Hospital
Kansas City, Kansas, United States
Active, not recruiting
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States
Active, not recruiting
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States
Active, not recruiting
The University of Kansas Cancer Center
Westwood, Kansas, United States
Active, not recruiting
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States
Active, not recruiting
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Active, not recruiting
Norton Hospital
Louisville, Kentucky, United States
Active, not recruiting
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Terminated
Brigham and Women's Hospital
Boston, Massachusetts, United States
Active, not recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Active, not recruiting
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, United States
Active, not recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Active, not recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Active, not recruiting
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Recruiting
Stephenson Cancer Center (chemo location)
Oklahoma City, Oklahoma, United States
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Recruiting
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
Recruiting
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
Recruiting
SCRI Oncology Partners
Nashville, Tennessee, United States
Recruiting
Texas Oncology - Austin Midtown
Austin, Texas, United States
Terminated
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, United States
Active, not recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Active, not recruiting
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, United States
Active, not recruiting
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States
Active, not recruiting
NEXT Dallas
Irving, Texas, United States
Recruiting
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
Terminated
US Oncology Investigational Products Center
Irving, Texas, United States
Terminated
NEXT Oncology
San Antonio, Texas, United States
Recruiting
NEXT Oncology
San Antonio, Texas, United States
Active, not recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Active, not recruiting
Olympic Medical Center
Port Angeles, Washington, United States
Active, not recruiting
Fred Hutchinson Cancer Center Alliance Peninsula
Poulsbo, Washington, United States
Active, not recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Active, not recruiting
University of Washington Medical Center
Seattle, Washington, United States
Active, not recruiting
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, Bulgaria
Terminated
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Active, not recruiting
Hunan Cancer Hospital
Changsha, Hunan, China
Active, not recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Active, not recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Active, not recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Active, not recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Active, not recruiting
In-Vivo Sp. z o.o. In-vivo Bydgoszcz
Bydgoszcz, Poland
Not yet recruiting
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, Poland
Active, not recruiting
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Poland
Recruiting
Centrum Medyczne MEDYK
Rzeszów, Poland
Active, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Poland
Active, not recruiting
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, Russia
Active, not recruiting
LLC "Neyro-klinika"
Moscow, Russia
Active, not recruiting
Showing 60 of 85 sites — filter to narrow it down. 23 of the 85 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03460977. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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