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

June 4, 2026 updated by: Pfizer

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 three parts (Part 1, Part 2, and Part 3) along with the Japan and China monotherapy cohorts. Part 1 and Part 2 are closed for enrollment. Part 1 tested monotherapy in 3 cohorts (Parts 1A, 1B, and 1C); Part 2 tested combination therapy in Parts 2A (dose escalation), 2B and 2C (does expansion).

Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body. The Sponsor may choose to delay or discontinue any cohorts or substudies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
453

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bulgaria
      • Haskovo, Bulgaria, 6300
        • Terminated
        • Specialized Hospital for Active Treatment of Oncology - Haskovo
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Active, not recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Active, not recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Active, not recruiting
        • National Cancer Center Hospital East
  • Poland
      • Koszalin, Poland, 75-581
        • Active, not recruiting
        • Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
      • Rzeszów, Poland, 35-326
        • Active, not recruiting
        • Centrum Medyczne MEDYK
      • Warsaw, Poland, 02-781
        • Active, not recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  • Russia
      • Moscow, Russia, 117186
        • Active, not recruiting
        • LLC "Neyro-klinika"
      • Moscow, Russia, 125284
        • Terminated
        • Moscow GBUZ "City clinical hospital n. a. S.P. Botkina" of Moscow health department
      • Moscow, Russia, 129301
        • Terminated
        • SBHI of Moscow City Clinical Hospital
      • Omsk, Russia, 644013
        • Terminated
        • Budgetary Healthcare Institution of Omsk region "Clinical Oncological Dispensary"
      • Saint Petersburg, Russia, 197341
        • Terminated
        • Federal State Budgetary Institution National Medical Research Center n.a. V.A. Almazov
      • Saint Petersburg, Russia, 197758
        • Terminated
        • Federal State Budgetary Institution National Medical Research Center for Oncology n.a. N.N.
      • Saint Petersburg, Russia, 198255
        • Terminated
        • Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"
      • Yaroslavl, Russia, 150054
        • Terminated
        • State Budgetary Healthcare Institution of the Yaroslavl Region
    • Sankt-Peterburg
      • Pushkin, Sankt-Peterburg, Russia, 196603
        • Active, not recruiting
        • Private Medical Institution "Euromedservice"
  • South Korea
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Active, not recruiting
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 07985
        • Active, not recruiting
        • Ewha Womans University Mokdong Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
        • Terminated
        • Severance Hospital, Yonsei University Health System
    • Taejǒn-kwangyǒkshi
      • Daejeon, Taejǒn-kwangyǒkshi, South Korea, 35015
        • Active, not recruiting
        • Chungnam national university hospital
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital Quironsalud Barcelona
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain, 28040
        • Recruiting
        • H.U. Fundación Jiménez Díaz
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Hospital Universitari i Politecnic La Fe
    • Barecelona
      • L'Hospitalet de Llobregat, Barecelona, Spain, 08908
        • Recruiting
        • Institut Català d´Oncología (ICO)-H. Durán i Reynals
    • Castellon
      • Castellon, Castellon, Spain, 12002
        • Active, not recruiting
        • Consorcio Hospitalario Provincial de Castellon
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Recruiting
        • Hospital Quironsalud Madrid
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Active, not recruiting
        • Banner-University Medical Center Tucson
      • Tucson, Arizona, United States, 85719
        • Active, not recruiting
        • The University of Arizona Cancer Center-North Campus
      • Tucson, Arizona, United States, 85724
        • Active, not recruiting
        • The University of Arizona Cancer Center
      • Tucson, Arizona, United States, 85741
        • Terminated
        • Arizona Urology Specialists, PLLC
    • California
      • Anaheim, California, United States, 92801
        • Active, not recruiting
        • Pacific Cancer Medical Center INC
      • Duarte, California, United States, 91010
        • Active, not recruiting
        • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
      • Duarte, California, United States, 91010
        • Active, not recruiting
        • City of Hope Investigational Drug Services (IDS)
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Active, not recruiting
        • Norwalk Hospital
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Active, not recruiting
        • The University of Kansas Cancer Center, Investigational Drug Services
      • Fairway, Kansas, United States, 66205
        • Active, not recruiting
        • The University of Kansas Clinical Research Center
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • The University of Kansas Hospital
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • The University of Kansas Medical Center Medical Office Building
      • Overland Park, Kansas, United States, 66211
        • Active, not recruiting
        • The University of Kansas Cancer Center - Indian Creek Campus
      • Westwood, Kansas, United States, 66205
        • Active, not recruiting
        • The University of Kansas Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Cancer Institute Pharmacy, Downtown Pharmacy
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Cancer Institute Pharmacy
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Cancer Institute, Norton Healthcare Pavilion
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Hospital
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Terminated
        • Maryland Oncology Hematology, P.A.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Dana Farber Cancer Institute
      • Newton, Massachusetts, United States, 02459
        • Active, not recruiting
        • Dana Farber Cancer Institute- Chestnut Hill
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • Hackensack University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • Active, not recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health University of Oklahoma Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center (chemo location)
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Parkway Surgery Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Austin, Texas, United States, 78705
        • Terminated
        • Texas Oncology - Austin Midtown
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • University of Texas Southwestern Medical Center - Simmons Cancer Center
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • UT Southwestern University Hospital - William P. Clements, Jr
      • Dallas, Texas, United States, 75390
        • Active, not recruiting
        • UT Southwestern University Hospital - Zale Lipshy
      • Irving, Texas, United States, 75063
        • Terminated
        • US Oncology Investigational Product Center (IPC)
      • Irving, Texas, United States, 75063
        • Terminated
        • US Oncology Investigational Products Center
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • NEXT Oncology
      • San Antonio, Texas, United States, 78240
        • Active, not recruiting
        • NEXT Oncology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Active, not recruiting
        • Virginia Cancer Specialists, PC
    • Washington
      • Port Angeles, Washington, United States, 98362
        • Active, not recruiting
        • Olympic Medical Center
      • Poulsbo, Washington, United States, 98370
        • Active, not recruiting
        • Fred Hutchinson Cancer Center Alliance Peninsula
      • Seattle, Washington, United States, 98195
        • Active, not recruiting
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Active, not recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Part 1 and Part 2 (Closed for enrollment).

Part 3 Key Inclusion Criteria:

  • 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

Part 3 Key Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation (Part 1A)
Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Experimental: Dose Escalation (Part 1B)
Participants with FL will receive mevrometostat at escalating dose levels
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Experimental: Dose Escalation (Part 2A)
Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Drug: Enzalutamide
Oral continuous
Other Names:
  • Xtandi
Experimental: Dose Expansion (Part 2B)
Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Drug: Enzalutamide
Oral continuous
Other Names:
  • Xtandi
Experimental: Japan Cohort
Participants with CRPC will receive mevrometostat at one or two doses
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Experimental: China cohort
Participants will receive mevrometostat at one or two doses
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
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
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Drug: Enzalutamide
Oral continuous
Other Names:
  • Xtandi
Experimental: BE Substudy
In 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.
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Drug: Enzalutamide
Oral continuous
Other Names:
  • Xtandi
Experimental: Dose Escalation (Part 1C)
Participants with mCRPC will receive mevrometostat at escalating dose levels.
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Experimental: DDI Substudy
The 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.
Drug: Itraconazole
Oral solution
Other Names:
  • Sporanox
  • Tolsura
  • Onmel
Drug: Mervometostat (PF-06821497)
Oral continuous
Other Names:
  • EZH2i
Drug: Enzalutamide
Oral continuous
Other Names:
  • Xtandi

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
Time Frame: Baseline up to 90 days
First cycle DLTs will be utilized to determine the MTD
Baseline up to 90 days
Overall safety profile including adverse events
Time Frame: Baseline up to approximately 2 years
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
Time Frame: Through study completion, approximately 2 years past last patient first visit.
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
Time Frame: Baseline up to approximately 2 years
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
Time Frame: Baseline up to approximately 2 years
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
Time Frame: Baseline until disease progression or death or through study completion (approx 2 years)
PCWG3
Baseline until disease progression or death or through study completion (approx 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate overall survival
Time Frame: Baseline up to approximately 2 years
Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.
Baseline up to approximately 2 years
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Single dose and multiple dose PK will be calculated as data permits
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Single dose and multiple dose PK will be calculated as data permits
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Area Under the Curve (AUC)
Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Single dose and multiple dose PK will be calculated as data permits
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Apparent Oral Clearance (CL/F)
Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Single dose and multiple dose PK will be calculated as data permits
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Apparent Volume of Distribution (Vz/F)
Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Single dose and multiple dose PK will be calculated as data permits
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Pharmacokinetic Parameters: Plasma Decay Half-Life (t1/2)
Time Frame: At specific timepoints from Cycle 1 day 1 to End of Treatment visit
Singe dose and multiple dose PK will be calculated as data permits
At specific timepoints from Cycle 1 day 1 to End of Treatment visit
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.
Time Frame: Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
Time to event endpoints based on 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)
Baseline and every 21 days through time of confirmed disease progression, unacceptable toxicity, or through study completion, approximately 2 years.
Evaluate the impact of mevrometostat on patient reported outcomes.
Time Frame: At specific time-points from Cycle 1 Day 1 to End of Treatment visit.
Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P.
At specific time-points from Cycle 1 Day 1 to End of Treatment visit.
Impact of mevrometostat in combination with enzalutamide, enzalutamide alone and mevrometostat alone on symptoms and symptomatic toxicity
Time Frame: At specific time points from Cycle1 Day 1 to end of treatment
Questionnaire customized from PRO-CTCAE.
At specific time points from Cycle1 Day 1 to end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C2321001
  • 2023-509179-18-00 (Registry Identifier: CTIS (EU))
  • EZH2 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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