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

Conditions

• Follicular Lymphoma (FL)
• Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mervometostat (PF-06821497) — DRUG
  Oral continuous
• Enzalutamide — DRUG
  Oral continuous
• Itraconazole — DRUG
  Oral solution

Study Details

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.

Key Dates

Start date

Apr 17, 2018

Status verified

Jun 2026

Primary completion

Apr 20, 2028

Completion

Jul 7, 2029

Study Design

Enrollment

453 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Escalation (Part 1A)
  Participants with SCLC, CRPC and FL will receive mevrometostat at escalating dose levels
• Experimental: Dose Escalation (Part 1B)
  Participants with FL will receive mevrometostat at escalating dose levels
• Experimental: Dose Escalation (Part 1C)
  Participants with mCRPC will receive mevrometostat at escalating dose levels.
• Experimental: Dose Escalation (Part 2A)
  Participants with mCRPC and SCLC will receive mevrometostat at escalating dose levels in combination with SOC.
• Experimental: Dose Expansion (Part 2B)
  Participants with CRPC will receive mevrometostat in combination with SOC or SOC alone.
• Experimental: Japan Cohort
  Participants with CRPC will receive mevrometostat at one or two doses
• Experimental: China cohort
  Participants will receive mevrometostat at one or two doses
• Experimental: Dose Expansion (Part 2C)
  Participants with mCRPC will receive mevrometostat at a different dose/dosing regimen than that of Part 2B in combination with SOC
• Experimental: BE Substudy
  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.
• Experimental: DDI Substudy
  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.

Primary Outcome Measure

Percentage of patients with dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) [ Time Frame: Baseline up to 90 days ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (45)

Find similar trials in Tucson, AZ

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