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RECRUITINGPhase 1INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Part 1 and Part 2 (Closed for enrollment). Part 3 Key Who May Qualify: - Histological or cytological diagnosis of castration resistant prostate cancer. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected expected to live at least 6 months. - Adequate bone marrow, renal, and liver function Part 3 Key Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Mervometostat (PF-06821497)

Oral continuous

DRUG

Enzalutamide

Oral continuous

DRUG

Itraconazole

Oral solution

Locations (20)

Banner-University Medical Center Tucson
Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States
Pacific Cancer Medical Center INC
Anaheim, California, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky, United States
Norton Cancer Institute Pharmacy
Louisville, Kentucky, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States