Viewing Study NCT06629779



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06629779
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-10

Brief Title: A Study to Learn How PF-06821497 Mevrometostat Works in Men With Metastatic Castration-resistant Prostate Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: A Phase 3 Randomized Double Blind Placebo Controlled Study of Pf-06821497 Mevrometostat With Enzalutamide in Metastatic Castration Resistant Prostate Cancer Mevpro-2
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve
Detailed Description: This is a global multicenter randomized Phase 3 study evaluating PF-06821497 mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT androgen deprivation therapy and first-generation anti-androgen agents Prior treatment with any of the ARSis enzalutamide darolutamide apalutamide or abiraterone acetate is not permitted in any setting Chemotherapy is permitted in the castrate sensitive setting

This study consists of a Screening Phase Randomization Treatment Phase Safety Follow-up and Long-Term Follow-up Participants will be randomized on a 11 basis to receive Arm A PF-06821497 in combination with enzalutamide or Arm B placebo in combination with enzalutamide

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None