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)

Who is this study for? Adult patients with relapsed/refractory small cell lung cancer, castration-resistant prostate cancer and follicular lymphoma
What treatments are being studied? PF-06821497
Status: Recruiting
Location: See all (104) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

‣ 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 received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) Japan cohort

⁃ Castration resistant prostate cancer that is resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients should have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression (per PCWG3) China cohort

⁃ Castration resistant prostate cancer that is intolerant/resistant to SOC or for which no local regulatory approved SOC is available that would confer significant clinical benefit in the medical judgement of the investigator. Patients who refused SOC may be eligible. Patients should have received either abiraterone and/or enzalutamide 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 received abiraterone treatment, may have received up to 1 prior line of chemotherapy, have not received prior enzalutamide, apalutamide or darolutamide and have evidence of prostate 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.

Locations
United States
Arizona
Arizona Urology Specialists, PLLC
RECRUITING
Tucson
Banner-University Medical Center Tucson
ACTIVE_NOT_RECRUITING
Tucson
The University of Arizona Cancer Center
ACTIVE_NOT_RECRUITING
Tucson
The University of Arizona Cancer Center-North Campus
ACTIVE_NOT_RECRUITING
Tucson
Urological Associates of Southern Arizona, P.C .
RECRUITING
Tucson
Urological Associates of Southern Arizona, PC
RECRUITING
Tucson
California
Pacific Cancer Medical Center INC
ACTIVE_NOT_RECRUITING
Anaheim
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
ACTIVE_NOT_RECRUITING
Duarte
City of Hope Investigational Drug Services (IDS)
ACTIVE_NOT_RECRUITING
Duarte
Connecticut
Norwalk Hospital
RECRUITING
Norwalk
Kansas
The University of Kansas Cancer Center, Investigational Drug Services
ACTIVE_NOT_RECRUITING
Fairway
The University of Kansas Clinical Research Center
ACTIVE_NOT_RECRUITING
Fairway
The University of Kansas Hospital
ACTIVE_NOT_RECRUITING
Kansas City
The University of Kansas Medical Center Medical Office Building
ACTIVE_NOT_RECRUITING
Kansas City
The University of Kansas Cancer Center - Indian Creek Campus
ACTIVE_NOT_RECRUITING
Overland Park
The University of Kansas Cancer Center
ACTIVE_NOT_RECRUITING
Westwood
Kentucky
Norton Cancer Institute Pharmacy
ACTIVE_NOT_RECRUITING
Louisville
Norton Cancer Institute Pharmacy, Downtown Pharmacy
ACTIVE_NOT_RECRUITING
Louisville
Norton Cancer Institute, Norton Healthcare Pavilion
ACTIVE_NOT_RECRUITING
Louisville
Norton Hospital
ACTIVE_NOT_RECRUITING
Louisville
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Dana Farber Cancer Institute- Chestnut Hill
RECRUITING
Newton
Maryland
Maryland Oncology Hematology, P.A.
TERMINATED
Rockville
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Hackensack University Medical Center
ACTIVE_NOT_RECRUITING
Hackensack
John Theurer Cancer Center at Hackensack University Medical Center
ACTIVE_NOT_RECRUITING
Hackensack
Oklahoma
OU Health University of Oklahoma Medical Center
RECRUITING
Oklahoma City
Stephenson Cancer Center
RECRUITING
Oklahoma City
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Parkway Surgery Center
RECRUITING
Myrtle Beach
Tennessee
Tennessee Oncology, PLLC
RECRUITING
Dickson
Tennessee Oncology PLLC
RECRUITING
Franklin
Tennessee Oncology, PLLC
RECRUITING
Gallatin
Tenessee Oncology, PLLC
RECRUITING
Hendersonville
Tennessee Oncology, PLLC
RECRUITING
Hermitage
Tennessee Oncology, PLLC
RECRUITING
Lebanon
Tennessee Oncology PLLC
RECRUITING
Murfreesboro
Sarah Cannon Research Institute - Pharmacy
RECRUITING
Nashville
Tennessee Oncolgy, PLLC
RECRUITING
Nashville
Tennessee Oncology PLLC
RECRUITING
Nashville
Tennessee Oncology PLLC
RECRUITING
Nashville
Tennessee Oncology-PLLC
RECRUITING
Nashville
Tennessee Oncology, PLLC
RECRUITING
Nashville
Tennessee Oncology, PLLC
RECRUITING
Nashville
Tennessee Oncology, PLLC
RECRUITING
Nashville
The Sarah Cannon Research Institute
RECRUITING
Nashville
Tennessee Oncology, PLLC
RECRUITING
Shelbyville
Tennessee Oncology, PLLC
RECRUITING
Smyrna
Texas
Texas Oncology - Austin Midtown
TERMINATED
Austin
University of Texas Southwestern Medical Center - Simmons Cancer Center
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
UT Southwestern University Hospital - William P. Clements, Jr
RECRUITING
Dallas
UT Southwestern University Hospital - Zale Lipshy
RECRUITING
Dallas
US Oncology Investigational Product Center (IPC)
TERMINATED
Irving
US Oncology Investigational Products Center
TERMINATED
Irving
NEXT Oncology
ACTIVE_NOT_RECRUITING
San Antonio
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Washington
Olympic Medical Center
RECRUITING
Port Angeles
Fred Hutchinson Cancer Center Alliance Peninsula
RECRUITING
Poulsbo
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Seattle Cancer Care Alliance
RECRUITING
Seattle
University of Washington Medical Center
RECRUITING
Seattle
Other Locations
Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
TERMINATED
Haskovo
China
Hunan Cancer Hospital
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Japan
National Cancer Center Hospital East
ACTIVE_NOT_RECRUITING
Kashiwa
Poland
Centrum Diagnostyczne Affidea Koszalin
ACTIVE_NOT_RECRUITING
Koszalin
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
ACTIVE_NOT_RECRUITING
Koszalin
Centrum Medyczne MEDYK
ACTIVE_NOT_RECRUITING
Rzeszów
LUX MED Onkologia Sp. z o.o. Szpital Szamocka
NOT_YET_RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
ACTIVE_NOT_RECRUITING
Warsaw
Republic of Korea
Chungnam national university hospital
ACTIVE_NOT_RECRUITING
Daejeon
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Ewha Womans University Mokdong Hospital
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Russian Federation
LLC Neyro-klinika
ACTIVE_NOT_RECRUITING
Moscow
Moscow GBUZ City clinical hospital n. a. S.P. Botkina of Moscow health department
TERMINATED
Moscow
SBHI of Moscow City Clinical Hospital
TERMINATED
Moscow
Budgetary Healthcare Institution of Omsk region Clinical Oncological Dispensary
TERMINATED
Omsk
Private Medical Institution Euromedservice
ACTIVE_NOT_RECRUITING
Pushkin
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
TERMINATED
Saint Petersburg
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
TERMINATED
Saint Petersburg
Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨
ACTIVE_NOT_RECRUITING
Saint Petersburg
Saint Petersburg State Budgetary Healthcare Institution City Clinical Oncological Dispensary
TERMINATED
Saint Petersburg
State Budgetary Healthcare Institution of the Yaroslavl Region
TERMINATED
Yaroslavl
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Quironsalud Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Consorcio Hospitalario Provincial de Castellon
ACTIVE_NOT_RECRUITING
Castellon
Institut Català d´Oncología (ICO)-H. Durán i Reynals
RECRUITING
L'hospitalet De Llobregat
H.U. Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
START Madrid CIOCC - HM Sanchinarro Hospital
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2018-04-17
Estimated Completion Date: 2026-03-19
Participants
Target number of participants: 343
Treatments
Experimental: Dose Escalation (Part 1A)
Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
Experimental: Dose Escalation (Part 1B)
Participants with FL will receive mevrometostat at escalating dose levels
Experimental: Dose Escalation (Part 1C)
Participants with mCRPC will receive PF-06821497 at escalating dose levels.
Experimental: Dose Escalation (Part 2A)
Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
Experimental: Dose Expansion (Part 2B)
Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
Experimental: Japan Cohort
Participants with CRPC will receive mevrometostat at one or two doses
Experimental: China cohort
Participants will receive mevrometostat at one or two doses
Experimental: Dose Expansion (Part 2C)
Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov