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

This study is looking at the safety and effects of a medicine called Mevrometostat, sometimes combined with Enzalutamide, for certain cancers. While earlier parts of the study for Small Cell Lung Cancer (SCLC) and Follicular Lymphoma (FL) are closed, the study is currently enrolling men with Castration Resistant Prostate Cancer (CRPC). To join, you must have CRPC, have already received treatment for it, and your cancer has progressed. The main goals are to find the safest dose of Mevrometostat, understand its side effects, and see how well it works against the cancer. You would receive Mevrometostat and/or Enzalutamide.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a multi-center study, and the planned enrollment is 453 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to approximately 2 years, and preliminary effectiveness will be assessed through study completion, about 2 years after the last patient's first visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03460977

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pfizer
~453 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Mervometostat (PF-06821497)EnzalutamideItraconazole

At a glance

Recruiting sites
25 of 84 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
Measured over Baseline up to 90 days
+5 more outcomes measured

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)
Small Cell Lung Cancer (SCLC)
Follicular Lymphoma (FL)

Explore related trials

Follicular LymphomaLung Small Cell CarcinomaProstate Carcinoma

Where it's being run

84 sites across 32 states
Spain10
Texas9
Russia8
Kansas6
Poland5
Arizona4
Washington4
California3

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)Baseline up to 90 days

    First cycle DLTs will be utilized to determine the MTD

  • Overall safety profile including adverse eventsBaseline up to approximately 2 years

    Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])

  • Preliminary efficacy determination as evaluated by disease specific response criteriaThrough 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.

  • Overall safety profile including laboratory abnormalitiesBaseline up to approximately 2 years

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.

  • Overall safety profile including vital signsBaseline up to approximately 2 years

    Vital sign changes from baseline including blood pressure, heart rate, ECG changes.

  • Evaluate time to event mevrometostat and enzalutamide vs enzalutamide alone including radiographic prgression free survivalBaseline until disease progression or death or through study completion (approx 2 years)

    PCWG3