Sign in

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

Full criteria on ClinicalTrials.gov

Sites (87)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Coordinator of this site? Confirm its status
HaskovoBulgariaCompleted
Complex Oncological Center - Plovdiv, EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaCompleted
Complex Oncology Center Ruse EOOD
Coordinator of this site? Confirm its status
RuseBulgariaCompleted
Complex Oncology Center Vratsa EOOD
Coordinator of this site? Confirm its status
VratsaBulgariaCompleted
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaActive, not recruiting
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The First Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaActive, not recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Coordinator of this site? Confirm its status
NanjingChinaActive, not recruiting
Zhongda Hospital Southeast University
Coordinator of this site? Confirm its status
NanjingChinaActive, not recruiting
The First Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaActive, not recruiting
Hospital Quirónsalud Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Consorcio Hospitalario Provincial De Castellon
Coordinator of this site? Confirm its status
Castello De La PlanaSpainRecruiting
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting
Hospital Universitario Ramón y Cajal
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario HM Sanchinarro
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Universitario Quironsalud Madrid
Coordinator of this site? Confirm its status
Pozuelo de AlarcónSpainRecruiting
Hospital Universitario Y Politecnico La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
National Cancer Center Hospital East
Coordinator of this site? Confirm its status
KashiwaJapanActive, not recruiting
Chungnam National University Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaActive, not recruiting
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
SeongnamSouth KoreaRecruiting
Ewha Womans University Mokdong Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaActive, not recruiting
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaActive, not recruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaActive, not recruiting
In- Vivo Sp. z o. o.
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Jagiellonskie Centrum Innowacji Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandRecruiting
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
Coordinator of this site? Confirm its status
KoszalinPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
SBHI of Moscow City Clinical Hospital
Coordinator of this site? Confirm its status
MoscowRussiaTerminated
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
Coordinator of this site? Confirm its status
MoscowRussiaTerminated
LLC "Neyro-klinika"
Coordinator of this site? Confirm its status
MoscowRussiaActive, not recruiting
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
Coordinator of this site? Confirm its status
OmskRussiaTerminated
Private Medical Institution "Euromedservice"
Coordinator of this site? Confirm its status
PushkinRussiaActive, not recruiting
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Coordinator of this site? Confirm its status
Saint PetersburgRussiaTerminated
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
Coordinator of this site? Confirm its status
Saint PetersburgRussiaTerminated
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
Coordinator of this site? Confirm its status
Saint PetersburgRussiaTerminated
State Budgetary Healthcare Institution of the Yaroslavl Region
Coordinator of this site? Confirm its status
YaroslavlRussiaTerminated
Pacific Cancer Medical Center INC
Coordinator of this site? Confirm its status
AnaheimUnited StatesActive, not recruiting
Texas Oncology-Austin Midtown
Coordinator of this site? Confirm its status
AustinUnited StatesTerminated
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesActive, not recruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesActive, not recruiting
UT Southwestern University Hospital - Zale Lipshy
Coordinator of this site? Confirm its status
DallasUnited StatesActive, not recruiting
UT Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesActive, not recruiting
University of Texas Southwestern Medical Center - Simmons Cancer Center
Coordinator of this site? Confirm its status
DallasUnited StatesActive, not recruiting
UT Southwestern University Hospital - William P. Clements, Jr
Coordinator of this site? Confirm its status
DallasUnited StatesActive, not recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Coordinator of this site? Confirm its status
DuarteUnited StatesActive, not recruiting
City of Hope Investigational Drug Services (IDS)
Coordinator of this site? Confirm its status
DuarteUnited StatesActive, not recruiting
Virginia Cancer Specialists PC
Coordinator of this site? Confirm its status
FairfaxUnited StatesActive, not recruiting
The University of Kansas - Clinical Research Center
Coordinator of this site? Confirm its status
FairwayUnited StatesActive, not recruiting
The University of Kansas Cancer Center, Investigational Drug Services
Coordinator of this site? Confirm its status
FairwayUnited StatesActive, not recruiting
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesActive, not recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesActive, not recruiting
NEXT Dallas
Coordinator of this site? Confirm its status
IrvingUnited StatesRecruiting
US Oncology Investigational Product Center (IPC)
Coordinator of this site? Confirm its status
IrvingUnited StatesTerminated
US Oncology Investigational Products Center
Coordinator of this site? Confirm its status
IrvingUnited StatesTerminated
The University of Kansas Medical Center Medical Office Building
Coordinator of this site? Confirm its status
Kansas CityUnited StatesActive, not recruiting
The University of Kansas Hospital
Coordinator of this site? Confirm its status
Kansas CityUnited StatesActive, not recruiting
Norton Hospital
Coordinator of this site? Confirm its status
LouisvilleUnited StatesActive, not recruiting
Norton Cancer Institute, Downtown
Coordinator of this site? Confirm its status
LouisvilleUnited StatesActive, not recruiting
Norton Cancer Institute, Norton Healthcare Pavilion
Coordinator of this site? Confirm its status
LouisvilleUnited StatesActive, not recruiting
Carolina Urologic Research Center
Coordinator of this site? Confirm its status
Myrtle BeachUnited StatesRecruiting
Parkway Surgery Center
Coordinator of this site? Confirm its status
Myrtle BeachUnited StatesRecruiting
SCRI Oncology Partners
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Sarah Cannon Research Institute- Pharmacy
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Dana-Farber Cancer Institute - Chestnut Hill
Coordinator of this site? Confirm its status
NewtonUnited StatesActive, not recruiting
Norwalk Hospital
Coordinator of this site? Confirm its status
NorwalkUnited StatesActive, not recruiting
Stephenson Cancer Center (chemo location)
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
OU Health University of Oklahoma Medical Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesRecruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
The University of Kansas Cancer Center - Indian Creek Campus
Coordinator of this site? Confirm its status
Overland ParkUnited StatesActive, not recruiting
Olympic Medical Center
Coordinator of this site? Confirm its status
Port AngelesUnited StatesActive, not recruiting
Fred Hutchinson Cancer Center Alliance Peninsula
Coordinator of this site? Confirm its status
PoulsboUnited StatesActive, not recruiting
Maryland Oncology Hematology, P.A.
Coordinator of this site? Confirm its status
RockvilleUnited StatesTerminated
NEXT Oncology
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Fred Hutchinson Cancer Center
Coordinator of this site? Confirm its status
SeattleUnited StatesActive, not recruiting
University of Washington Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesActive, not recruiting
The University of Arizona Cancer Center-North Campus
Coordinator of this site? Confirm its status
TucsonUnited StatesActive, not recruiting
Arizona Urology Specialists, PLLC
Coordinator of this site? Confirm its status
TucsonUnited StatesTerminated
The University of Arizona Cancer Center
Coordinator of this site? Confirm its status
TucsonUnited StatesActive, not recruiting
Banner University Medical Center - Tucson
Coordinator of this site? Confirm its status
TucsonUnited StatesActive, not recruiting
The University of Kansas Cancer Center
Coordinator of this site? Confirm its status
WestwoodUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.