Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT03460977

Recruiting

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

Interventional

Phase 1

Hackensack University Medical Center

Sponsor: Pfizer

Last Updated: March 13, 2026
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Show Detailed Description

Treatment Category

Targeted Therapy, Hormone Therapy, Other Drugs

Required Mutations

None

Trial Started

April 17, 2018

Last Updated by Sponsor

March 13, 2026

Estimated Completion

April 20, 2028

Contact Study

Name:Pfizer CT.gov Call Center

Email:ClinicalTrials.gov_Inquiries@pfizer.com

Phone:1-800-718-1021

Eligibility

Inclusion Criteria

Part 1 and Part 2 (Closed for enrollment).

* 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 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

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Design Details

AllocationNon-Randomized

Intervention ModelSequential Assignment

MaskingNone (Open Label)

Number to Enroll453

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels

Interventions:

Mervometostat (PF-06821497)
Enzalutamide
Itraconazole

Outcome Measures

Primary Outcome Measures

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.

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.

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

Secondary Outcome Measures

Evaluate overall survivalBaseline up to approximately 2 years

Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.

Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)At specific timepoints from Cycle 1 day 1 to End of Treatment visit