Phase
Condition
Small Cell Lung Cancer
Follicular Lymphoma
Urologic Cancer
Treatment
Mervometostat (PF-06821497)
PF-06821497
Enzalutamide
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300
BulgariaTerminated
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
BulgariaSite Not Available
Complex Oncology Center - Ruse EOOD
Ruse, 7002
BulgariaSite Not Available
"Complex Oncology Center - Vratsa" EOOD
Vratsa, 3000
BulgariaSite Not Available
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong 510120
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaActive - Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
ChinaActive - Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
ChinaActive - Recruiting
West China Hospital, Sichuan University
Cheng Du, Sichuan 610041
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaActive - Recruiting
Azienda Ospedaliero - Universitaria Senese
Siena, (si) 53100
ItalySite Not Available
SOD Farmacia Azienda Ospedaliero Universitaria
Torette Di Ancona, AN 60126
ItalySite Not Available
U.O. Farmacia- I.R.S.T. SRL IRCCS
Meldola, FC 47014
ItalySite Not Available
S.C. Centro Di Ricerca Fase 1 Asst Monza
Monza, MB 20900
ItalySite Not Available
Rugani Hospital SRL
Monteriggioni, SI 53035
ItalySite Not Available
U. O. Ematologia e Trapianto Midollo Osseo IRCCS OSPEDALE SAN RAFFAELE
Milano, 20132
ItalySite Not Available
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
JapanSite Not Available
National Cancer Center
Goyang-si, Kyǒnggi-do 10408
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do 13620
Korea, Republic ofActive - Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul] 06273
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 05505
Korea, Republic ofActive - Recruiting
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul] 07985
Korea, Republic ofActive - Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 06273
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi 41404
Korea, Republic ofActive - Recruiting
Chungnam national university hospital
Daejeon, Taejǒn-kwangyǒkshi 35015
Korea, Republic ofActive - Recruiting
Centrum Diagnostyczne Affidea Koszalin
Koszalin, 75-900
PolandSite Not Available
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, 75-581
PolandSite Not Available
Centrum Medyczne MEDYK
Rzeszow, 35-326
PolandSite Not Available
LUX MED Onkologia Sp. z o.o. Szpital Szamocka
Warszawa, 01-748
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warszawa, 02-781
PolandSite Not Available
Private Medical Institution "Euromedservice"
Pushkin, Saint - Petersburg 196603
Russian FederationSite Not Available
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
Pushkin, Saint Petersburg 196603
Russian FederationSite Not Available
Private medical institution "Euromedservice"
Pushkin, Saint-petersburg 196603
Russian FederationSite Not Available
LLC "Neyro-klinika"
Moscow, 117186
Russian FederationSite Not Available
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
Moscow, 125284
Russian FederationTerminated
SBHI of Moscow City Clinical Hospital
Moscow, 129301
Russian FederationTerminated
GBUZ of the Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhny Novgorod, 603126
Russian FederationSite Not Available
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
Omsk, 644013
Russian FederationTerminated
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
Saint Petersburg, 197341
Russian FederationTerminated
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Saint Petersburg, 198255
Russian FederationTerminated
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
Saint-Petersburg, 197758
Russian FederationTerminated
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
Saint-Petersburg, 195271
Russian FederationSite Not Available
Private Healthcare Institution "Clinical hospital "RZD-Medicine" of Saint-Petersburg
Saint-Petersburg, 195271
Russian FederationSite Not Available
State Budgetary Healthcare Institution of the Yaroslavl Region
Yaroslavl, 150054
Russian FederationTerminated
Institut Català d´Oncología (ICO)-H. Durán i Reynals
L'Hospitalet de Llobregat, Barecelona 08908
SpainActive - Recruiting
Onkologikoa
San Sebastian, Guipuzcoa 20014
SpainSite Not Available
Hospital Quironsalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainActive - Recruiting
Consorcio Hospitalario Provincial de Castellon
Castellon de la Plana, Valencia 12002
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital HM Nou Delfos
Barcelona, 08023
SpainSite Not Available
Hospital Quironsalud Barcelona
Barcelona, 08023
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainSite Not Available
Consorcio Hospitalario Provincial de Castellon
Castellon, 12002
SpainActive - Recruiting
H.U. Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Malaga, 29010
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
València, 46026
SpainActive - Recruiting
Banner-University Medical Center Tucson
Tucson, Arizona 85719
United StatesSite Not Available
The University of Arizona Cancer Center
Tucson, Arizona 85724
United StatesSite Not Available
The University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United StatesSite Not Available
Urological Associates of Southern Arizona, P.C .
Tucson, Arizona 85715
United StatesActive - Recruiting
Urological Associates of Southern Arizona, PC
Tucson, Arizona 85741
United StatesActive - Recruiting
Pacific Cancer Medical Center INC
Anaheim, California 92801
United StatesSite Not Available
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California 91010
United StatesSite Not Available
City of Hope Investigational Drug Services (IDS)
Duarte, California 91010
United StatesSite Not Available
Norwalk Hospital
Norwalk, Connecticut 06856
United StatesActive - Recruiting
Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Illinois CancerCare, P.C.
Peoria, Illinois 61615
United StatesSite Not Available
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas 66205
United StatesSite Not Available
The University of Kansas Clinical Research Center
Fairway, Kansas 66205
United StatesSite Not Available
The University of Kansas Hospital
Kansas City, Kansas 66160
United StatesSite Not Available
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas 66160
United StatesSite Not Available
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas 66211
United StatesSite Not Available
The University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesSite Not Available
Norton Cancer Institute Pharmacy
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
Maryland Oncology Hematology, P.A.
Rockville, Maryland 20850
United StatesTerminated
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Siteman Cancer Center - West County
Creve Coeur, Missouri 63141
United StatesSite Not Available
Washington University School of Medicine, Siteman Cancer Center
Saint Louis, Missouri 63110
United StatesSite Not Available
Siteman Cancer Center - St. Peters
Saint Peters, Missouri 63376
United StatesSite Not Available
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
CUMC Research Pharmacy
New York, New York 10032
United StatesSite Not Available
OU Medical Center Presbyterian Tower
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Prisma Health Cancer Inst- Faris
Greenville, South Carolina 29605
United StatesSite Not Available
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
Tennessee Oncolgy, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
The Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Texas Oncology - Austin Midtown
Austin, Texas 78705
United StatesTerminated
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
UT Southwestern Simmons Cancer Center
Dallas, Texas 75390
United StatesActive - Recruiting
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas 75390
United StatesActive - Recruiting
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas 75390
United StatesActive - Recruiting
University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy
Dallas, Texas 75390
United StatesActive - Recruiting
Texas Oncology -Fort Worth Cancer Center
Fort Worth, Texas 76104
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
US Oncology Investigational Product Center (IPC)
Irving, Texas 75063
United StatesTerminated
US Oncology Investigational Products Center
Irving, Texas 75063
United StatesTerminated
NEXT Oncology
San Antonio, Texas 78240
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesActive - Recruiting
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