NCT03460977 · Pfizer
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Mervometostat (PF-06821497)
Oral continuous
DRUG
Enzalutamide
Oral continuous
DRUG
Itraconazole
Oral solution
Primary outcome measures
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
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 \[4.03\])
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.
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.
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tucson, Arizona
- Anaheim, California
- Duarte, California
- Norwalk, Connecticut
- Fairway, Kansas
- Kansas City, Kansas
- Overland Park, Kansas
- Westwood, Kansas
- Louisville, Kentucky
- Rockville, Maryland
- Boston, Massachusetts
- Newton, Massachusetts
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations