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)
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Study 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.
To evaluate the pharmacokinetics (PK), safety, and antitumor activity of PF-06821497, a potent and selective inhibitor of EZH2, in an ongoing phase I trial (NCT03460977) in patients (pts) with SCLC, CRPC, and FL as monotherapy and in combination with standard of care therapies. To compare the safety and efficacy of twice-daily PF-06821497 in combination with E (160 mg daily) (treatment arm) versus E monotherapy (control arm) administered continuously in patients with mCRPC previously treated with abiraterone.
- 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:
- Part 3
- 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
Clinical Study Information for Healthcare Providers
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