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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 Follicular Lymphoma (FL), sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT03460977 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Follicular Lymphoma (FL) 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.
The verdict
NCT03460977, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Follicular Lymphoma (FL), 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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2029-07-07 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 383-participant average among 15 other Metastatic Castration-Resistant Prostate Cancer (mCRPC) trials with a reported enrollment target (18% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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), Follicular Lymphoma (FL), Small Cell Lung Cancer (SCLC).
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.
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