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NCT03460977 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Small Cell Lung Cancer (SCLC), sponsored by Pfizer.

Recruiting
Registry status
Phase 1
Development phase
453
Enrollment target
20
Study locations

NCT03460977: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Small Cell Lung Cancer (SCLC), sponsored by Pfizer.

NCT03460977 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Small Cell Lung Cancer (SCLC) that is actively recruiting participants, run by Pfizer. The registered enrollment target is 453 participants, above the 383-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03460977, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Small Cell Lung Cancer (SCLC), is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 1
Development phase
453 participants
Enrollment target
20
Study locations

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.

Primary Outcome

First cycle DLTs will be utilized to determine the MTD

Conditions Studied

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

Interventions

  • DRUG Enzalutamide
  • DRUG Itraconazole
  • DRUG Mervometostat (PF-06821497)

Study Locations (20)

Kansas

  • The University of Kansas Cancer Center, Investigational Drug Services - Fairway
  • The University of Kansas Clinical Research Center - Fairway
  • The University of Kansas Hospital - Kansas City
  • The University of Kansas Medical Center Medical Office Building - Kansas City
  • The University of Kansas Cancer Center - Indian Creek Campus - Overland Park
  • The University of Kansas Cancer Center - Westwood

Arizona

  • Banner-University Medical Center Tucson - Tucson
  • The University of Arizona Cancer Center-North Campus - Tucson
  • The University of Arizona Cancer Center - Tucson
  • Arizona Urology Specialists, PLLC - Tucson

Kentucky

  • Norton Cancer Institute Pharmacy, Downtown Pharmacy - Louisville
  • Norton Cancer Institute Pharmacy - Louisville
  • Norton Cancer Institute, Norton Healthcare Pavilion - Louisville
  • Norton Hospital - Louisville

California

  • Pacific Cancer Medical Center INC - Anaheim
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center) - Duarte
  • City of Hope Investigational Drug Services (IDS) - Duarte

Connecticut

  • Norwalk Hospital - Norwalk

Maryland

  • Maryland Oncology Hematology, P.A. - Rockville

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 453 participants
Start Date 2018-04-17
Est. Completion 2029-07-07
Phase Phase 1
Pfizer

1,845 total trials

What NCT03460977 shows while recruiting

NCT03460977 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 383-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (18% higher).

The record links to 3 conditions, with Metastatic Castration-Resistant Prostate Cancer (mCRPC) appearing as the primary indexed condition, and to 3 interventions - of which Enzalutamide is the first listed.

NCT03460977 names 20 study sites across 7 states, led by Kansas, Arizona, Kentucky.

Frequently Asked Questions

What is clinical trial NCT03460977 about?

NCT03460977 is a clinical study titled "A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma". 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; P...

What is the current status of trial NCT03460977?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 453 participants. The study started on 2018-04-17. Estimated completion is 2029-07-07.

What conditions does trial NCT03460977 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC), Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL).

What interventions are being tested in trial NCT03460977?

The interventions under investigation include: Enzalutamide (DRUG), Itraconazole (DRUG), Mervometostat (PF-06821497) (DRUG).

Who is sponsoring clinical trial NCT03460977?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03460977 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03460977's enrollment target sits among peer trials

453 5th of 15 higher than 11 of 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT03460977

Source: ClinicalTrials.gov NCT03460977, the US trial registry maintained by the National Library of Medicine. NCT03460977 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.