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RECRUITING Phase 1

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

NCT03460977 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03460977

The ClinicalTrials.gov registry entry for NCT03460977 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Follicular Lymphoma (FL) appearing as the primary indexed condition, and to 3 interventions — of which Enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03460977 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Kansas, Arizona, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Follicular Lymphoma (FL), Small Cell Lung Cancer (SCLC), Metastatic Castration Resistant Prostate Cancer (mCRPC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03460977?

The interventions under investigation include: Enzalutamide (DRUG), Itraconazole (DRUG), Mervometostat (PF-06821497) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03460977?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial