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A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
Sponsor: Pfizer
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
453
Start Date
2018-04-17
Completion Date
2029-07-07
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Mervometostat (PF-06821497)
Oral continuous
Enzalutamide
Oral continuous
Itraconazole
Oral solution
Locations (82)
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 (chemo location)
Oklahoma City, Oklahoma, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, United States
SCRI Oncology Partners
Nashville, 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
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
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
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
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain