At a glance
ClinicalIndex Comparison Record- ✓Histological or cytological diagnosis of castration resistant prostate cancer
- ✓ECOG Performance Status 0-2 with life expectancy of at least 6 months
- ✓Adequate bone marrow, renal, and liver function
- ✕Prior irradiation to >25% of bone marrow
- ✕QTcF interval >480 msec at screening
- ✕Hypertension uncontrolled by medications (>150/90 mmHg despite optimal therapy)
- ✕Known or suspected hypersensitivity to PF-06821497 or enzalutamide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Mervometostat (PF-06821497), Enzalutamide, and 1 other intervention for Metastatic Castration Resistant Prostate Cancer (mCRPC) and 2 related conditions. Currently recruiting, targeting 453 participants across 83 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
Participants with FL will receive mevrometostat at escalating dose levels
Participants with mCRPC will receive mevrometostat at escalating dose levels.
Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
Participants with CRPC will receive mevrometostat at one or two doses
Participants will receive mevrometostat at one or two doses
Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC
In the assessment phase, each enrolled participant will receive single doses of the 2 different mevrometostat formulations in 3 periods with alternating dosing and washout between each dose. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.
The DDI substudy assessment phase will consist of 2 Cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (combination cohort). In the Cohort 1 assessment phase, each enrolled participant will receive a combination of mevrometostat and itraconazole based on preset schedule. In the Cohort 2 assessment phase, each enrolled participant will receive a combination of mevrometostat, enzalutamide, and itraconazole based on preset schedule. In the maintenance phase, each participant will receive mevrometostat 2 times a day and enzalutamide 1 time a day.
Interventions
Oral continuous
Oral continuous
Oral solution