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)
3 other identifiers
interventional
453
8 countries
82
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2018
Longer than P75 for phase_1
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedStudy Start
First participant enrolled
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 7, 2029
May 5, 2026
May 1, 2026
10 years
February 12, 2018
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
First cycle DLTs will be utilized to determine the MTD
Baseline up to 90 days
Overall safety profile including adverse events
Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])
Baseline up to approximately 2 years
Preliminary efficacy determination as evaluated by disease specific response criteria
Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.
Through study completion, approximately 2 years past last patient first visit.
Overall safety profile including laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.
Baseline up to approximately 2 years
Overall safety profile including vital signs
Vital sign changes from baseline including blood pressure, heart rate, ECG changes.
Baseline up to approximately 2 years
Evaluate time to event mevrometostat and enzalutamide vs enzalutamide alone including radiographic prgression free survival
PCWG3
Baseline until disease progression or death or through study completion (approx 2 years)
Secondary Outcomes (10)
Evaluate time to event anti-tumor activity of mevrometostat including progression-free survival (PFS), PSA50, Duration of Response (DoR), Time to first skeletal related event and Time to symptomatic skeletal related event, depending on tumor type.
Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
Evaluate overall survival
Baseline up to approximately 2 years
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Area Under the Curve (AUC)
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
- +5 more secondary outcomes
Study Arms (10)
Dose Escalation (Part 1A)
EXPERIMENTALParticipants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
Dose Escalation (Part 1B)
EXPERIMENTALParticipants with FL will receive mevrometostat at escalating dose levels
Dose Escalation (Part 1C)
EXPERIMENTALParticipants with mCRPC will receive mevrometostat at escalating dose levels.
Dose Escalation (Part 2A)
EXPERIMENTALParticipants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
Dose Expansion (Part 2B)
EXPERIMENTALParticipants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
Japan Cohort
EXPERIMENTALParticipants with CRPC will receive mevrometostat at one or two doses
China cohort
EXPERIMENTALParticipants will receive mevrometostat at one or two doses
Dose Expansion (Part 2C)
EXPERIMENTALParticipants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC
BE Substudy
EXPERIMENTALIn the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.
DDI Substudy
EXPERIMENTALThe DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.
Interventions
Oral continuous
Oral continuous
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (82)
Banner-University Medical Center Tucson
Tucson, Arizona, 85719, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, 85741, United States
Pacific Cancer Medical Center INC
Anaheim, California, 92801, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, 66205, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, 66160, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky, 40202, United States
Norton Cancer Institute Pharmacy
Louisville, Kentucky, 40202, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, 02459, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104, United States
Stephenson Cancer Center (chemo location)
Oklahoma City, Oklahoma, 73104, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572, United States
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology - Austin Midtown
Austin, Texas, 78705, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75390, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, 75390, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center
Irving, Texas, 75063, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
NEXT Oncology
San Antonio, Texas, 78240, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Olympic Medical Center
Port Angeles, Washington, 98362, United States
Fred Hutchinson Cancer Center Alliance Peninsula
Poulsbo, Washington, 98370, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98109, United States
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300, Bulgaria
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, 75-581, Poland
Centrum Medyczne MEDYK
Rzeszów, 35-326, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, 02-781, Poland
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
LLC "Neyro-klinika"
Moscow, 117186, Russia
Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
Moscow, 125284, Russia
SBHI of Moscow City Clinical Hospital
Moscow, 129301, Russia
Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
Omsk, 644013, Russia
Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
Saint Petersburg, 197341, Russia
Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
Saint Petersburg, 197758, Russia
Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
Saint Petersburg, 198255, Russia
State Budgetary Healthcare Institution of the Yaroslavl Region
Yaroslavl, 150054, Russia
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul], 07985, South Korea
Chungnam national university hospital
Daejeon, Taejǒn-kwangyǒkshi, 35015, South Korea
Institut Català d´Oncología (ICO)-H. Durán i Reynals
L'Hospitalet de Llobregat, Barecelona, 08908, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon, Castellon, 12002, Spain
Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Quironsalud Barcelona
Barcelona, 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
H.U. Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 De Octubre
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2018
First Posted
March 9, 2018
Study Start
April 17, 2018
Primary Completion (Estimated)
April 20, 2028
Study Completion (Estimated)
July 7, 2029
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.