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

Condition(s) studied

Investigational drug(s) / intervention(s)

Mervometostat (PF-06821497): Oral continuous

Enzalutamide: Oral continuous

Itraconazole: Oral solution

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.

Eligibility

Primary outcome measure(s)

• 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 events — 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 — 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 — 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 — 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 — Baseline until disease progression or death or through study completion (approx 2 years)
  PCWG3

Trial sites (84)

+ 44 more sites — see the full list on the official registry below.