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

About This Trial

This study is testing an experimental pill called mevrometostat to see if it is safe and effective for men with advanced prostate cancer.
It is open to patients whose cancer has continued to grow or return after previous treatments.
During the study, participants will take the medication by mouth, sometimes alongside another standard prostate cancer drug, while doctors monitor how well it works and how it interacts with other medicines.
Before considering this trial, patients should know that they must be in relatively good overall health, and certain heart problems, stomach conditions, or other daily medications may prevent them from joining.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: All
Who This Trial is For: This study is testing an experimental pill called mevrometostat to see if it is safe and effective for men with advanced prostate cancer.

Study Details

Start Date: April 17, 2018
Lead Sponsor: Pfizer

Full Eligibility Criteria

Part 1 and Part 2 (Closed for enrollment).

Part 3 Key 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