Mevrometostat Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Last updated: April 11, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Follicular Lymphoma

Urologic Cancer

Treatment

Mervometostat (PF-06821497)

PF-06821497

Enzalutamide

Clinical Study ID

NCT03460977
C2321001
2023-509179-18-00
2018-001835-37
EZH2
  • Ages > 18
  • All Genders

Study Summary

A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 (Mevrometostat) in Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts:

Part 1A (closed to enrollment):

Part 1B (closed to enrollment):

Part 1C:

  • Metastatic Castration resistant prostate cancer. Patients should have receivedeither abiraterone and/or enzalutamide treatment and have evidence of prostatecancer progression (per PCWG3) Japan cohort

  • Castration resistant prostate cancer that is resistant to SOC or for which no localregulatory approved SOC is available that would confer significant clinical benefitin the medical judgement of the investigator. Patients should have received eitherabiraterone and/or enzalutamide treatment and have evidence of prostate cancerprogression (per PCWG3) China cohort

  • Castration resistant prostate cancer that is intolerant/resistant to SOC or forwhich no local regulatory approved SOC is available that would confer significantclinical benefit in the medical judgement of the investigator. Patients who refusedSOC may be eligible. Patients should have received either abiraterone and/orenzalutamide treatment and have evidence of prostate cancer progression (per PCWG3)

Part 2A:

• Metastatic Castration resistant prostate cancer. Patients should have received either abiraterone and/or enzalutamide treatment, may have received up to 1 line of chemotherapy and have evidence of prostate cancer progression (per PCWG3)

Part 2B/2C:

  • Metastatic Castration resistant prostate cancer. Patients should have receivedabiraterone treatment, may have received up to 1 prior line of chemotherapy, havenot received prior enzalutamide, apalutamide or darolutamide and have evidence ofprostate cancer progression (per PCWG3)

  • Patients must have radiographic evidence of disease

Other inclusion criteria:

-Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

Exclusion

Key Exclusion Criteria:

  • Prior Chemotherapy: Part 1C , Japan cohort and China cohort (CRPC): no more than 2previous regimens of chemotherapy Part 2A: mCRPC: no more than 1 previous regimen ofsystemic chemotherapy Part 2B (mCRPC): no more than 1 previous regimen ofchemotherapy

  • 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 optimalmedical therapy).

  • Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)

  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticulardisease or previous gastric resection or lap band surgery. Gastroesophageal refluxdisease under treatment with proton pump inhibitors is allowed.

  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5inducers or inhibitors, including their administration within 10 days or 5 halflives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose ofinvestigational product.

Study Design

Total Participants: 343
Treatment Group(s): 3
Primary Treatment: Mervometostat (PF-06821497)
Phase: 1
Study Start date:
April 17, 2018
Estimated Completion Date:
March 19, 2026

Study Description

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of mevrometostat (PF-06821497) administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. The study consists of Part 1, Part 2 and the Japan and China monotherapy cohorts Part 1A will evaluate safety and target modulation of mevrometostat monotherapy in patients with SCLC, FL and CRPC. Mevrometostat will be administered as monotherapy in escalating doses to patients with FL (Part 1B) and mCRPC (Part 1C) to determine the monotherapy MTD. In Part 2A (dose escalation, RP2D finding for dose escalation), mevrometostat will be administered in combination with SOC to patients with mCRPC and SCLC. Japan and China monotherapy cohorts will evaluate the safety, antitumor activity and PK of single agent mevrometostat in Japanese and Chinese patients. In Part 2B (dose expansion), patients with mCRPC will be randomized (1:1 ratio) to receive either SOC or mevrometostat in combination with SOC. Part 2B will assess the efficacy of mevrometostat at the RP2D in combination with SOC in patients with mCRPC in comparison to SOC alone. Part 2C will explore the efficacy of mevrometostat given at a different dose/dosing regimen than 2B in combination with SOC in patients with mCRPC.

Connect with a study center

  • Specialized Hospital for Active Treatment of Oncology - Haskovo

    Haskovo, 6300
    Bulgaria

    Terminated

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Ruse EOOD

    Ruse, 7002
    Bulgaria

    Site Not Available

  • "Complex Oncology Center - Vratsa" EOOD

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Azienda Ospedaliero - Universitaria Senese

    Siena, (si) 53100
    Italy

    Site Not Available

  • SOD Farmacia Azienda Ospedaliero Universitaria

    Torette Di Ancona, AN 60126
    Italy

    Site Not Available

  • U.O. Farmacia- I.R.S.T. SRL IRCCS

    Meldola, FC 47014
    Italy

    Site Not Available

  • S.C. Centro Di Ricerca Fase 1 Asst Monza

    Monza, MB 20900
    Italy

    Site Not Available

  • Rugani Hospital SRL

    Monteriggioni, SI 53035
    Italy

    Site Not Available

  • U. O. Ematologia e Trapianto Midollo Osseo IRCCS OSPEDALE SAN RAFFAELE

    Milano, 20132
    Italy

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Cancer Center

    Goyang-si, Kyǒnggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Gangnam-gu, Seoul-teukbyeolsi [seoul] 06273
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 05505
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 07985
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 06273
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul] 03722
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-kwangyǒkshi 41404
    Korea, Republic of

    Active - Recruiting

  • Chungnam national university hospital

    Daejeon, Taejǒn-kwangyǒkshi 35015
    Korea, Republic of

    Active - Recruiting

  • Centrum Diagnostyczne Affidea Koszalin

    Koszalin, 75-900
    Poland

    Site Not Available

  • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

    Koszalin, 75-581
    Poland

    Site Not Available

  • Centrum Medyczne MEDYK

    Rzeszow, 35-326
    Poland

    Site Not Available

  • LUX MED Onkologia Sp. z o.o. Szpital Szamocka

    Warszawa, 01-748
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

    Warszawa, 02-781
    Poland

    Site Not Available

  • Private Medical Institution "Euromedservice"

    Pushkin, Saint - Petersburg 196603
    Russian Federation

    Site Not Available

  • Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg

    Pushkin, Saint Petersburg 196603
    Russian Federation

    Site Not Available

  • Private medical institution "Euromedservice"

    Pushkin, Saint-petersburg 196603
    Russian Federation

    Site Not Available

  • LLC "Neyro-klinika"

    Moscow, 117186
    Russian Federation

    Site Not Available

  • Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department

    Moscow, 125284
    Russian Federation

    Terminated

  • SBHI of Moscow City Clinical Hospital

    Moscow, 129301
    Russian Federation

    Terminated

  • GBUZ of the Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"

    Omsk, 644013
    Russian Federation

    Terminated

  • Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov

    Saint Petersburg, 197341
    Russian Federation

    Terminated

  • Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"

    Saint Petersburg, 198255
    Russian Federation

    Terminated

  • Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.

    Saint-Petersburg, 197758
    Russian Federation

    Terminated

  • Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨

    Saint-Petersburg, 195271
    Russian Federation

    Site Not Available

  • Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg

    Saint-Petersburg, 195271
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution of the Yaroslavl Region

    Yaroslavl, 150054
    Russian Federation

    Terminated

  • Institut Català d´Oncología (ICO)-H. Durán i Reynals

    L'Hospitalet de Llobregat, Barecelona 08908
    Spain

    Active - Recruiting

  • Onkologikoa

    San Sebastian, Guipuzcoa 20014
    Spain

    Site Not Available

  • Hospital Quironsalud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Consorcio Hospitalario Provincial de Castellon

    Castellon de la Plana, Valencia 12002
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital HM Nou Delfos

    Barcelona, 08023
    Spain

    Site Not Available

  • Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, 12002
    Spain

    Active - Recruiting

  • H.U. Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • Banner-University Medical Center Tucson

    Tucson, Arizona 85719
    United States

    Site Not Available

  • The University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • The University of Arizona Cancer Center-North Campus

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Urological Associates of Southern Arizona, P.C .

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Urological Associates of Southern Arizona, PC

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • Pacific Cancer Medical Center INC

    Anaheim, California 92801
    United States

    Site Not Available

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope Investigational Drug Services (IDS)

    Duarte, California 91010
    United States

    Site Not Available

  • Norwalk Hospital

    Norwalk, Connecticut 06856
    United States

    Active - Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Illinois CancerCare, P.C.

    Peoria, Illinois 61615
    United States

    Site Not Available

  • The University of Kansas Cancer Center, Investigational Drug Services

    Fairway, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Clinical Research Center

    Fairway, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • The University of Kansas Medical Center Medical Office Building

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • The University of Kansas Cancer Center - Indian Creek Campus

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Norton Cancer Institute Pharmacy

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Cancer Institute Pharmacy, Downtown Pharmacy

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Cancer Institute, Norton Healthcare Pavilion

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Norton Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Maryland Oncology Hematology, P.A.

    Rockville, Maryland 20850
    United States

    Terminated

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri 63141
    United States

    Site Not Available

  • Washington University School of Medicine, Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Siteman Cancer Center - St. Peters

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • CUMC Research Pharmacy

    New York, New York 10032
    United States

    Site Not Available

  • OU Medical Center Presbyterian Tower

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Prisma Health Cancer Inst- Faris

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Tennessee Oncolgy, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology - Austin Midtown

    Austin, Texas 78705
    United States

    Terminated

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • UT Southwestern Simmons Cancer Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • UT Southwestern University Hospital - William P. Clements, Jr

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • UT Southwestern University Hospital - Zale Lipshy

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center - Simmons Cancer Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Texas Oncology -Fort Worth Cancer Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • US Oncology Investigational Product Center (IPC)

    Irving, Texas 75063
    United States

    Terminated

  • US Oncology Investigational Products Center

    Irving, Texas 75063
    United States

    Terminated

  • NEXT Oncology

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Active - Recruiting

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