Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03460977
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2018-02-12
Brief Title:
Mevrometostat Treatment of RelapsedRefractory SCLC Castration Resistant Prostate Cancer and Follicular Lymphoma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 MEVROMETOSTAT IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSEDREFRACTORY SMALL CELL LUNG CANCER SCLC CASTRATION RESISTANT PROSTATE CANCER CRPC AND FOLLICULAR LYMPHOMA FL
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 Mevrometostat in Adult Patients With RelapsedRefractory Small Cell Lung Cancer SCLC Castration Resistant Prostate Cancer CRPC And Follicular Lymphoma FL
Detailed Description:
This is an open label multi center Phase 1 dose escalation and dose expansion study of mevrometostat PF-06821497 administered orally BID as a single agent or in combination with SOC to patients with CRPC SCLC and FL The study consists of Part 1 Part 2 and the Japan and China monotherapy cohorts Part 1A will evaluate safety and target modulation of mevrometostat monotherapy in patients with SCLC FL and CRPC Mevrometostat will be administered as monotherapy in escalating doses to patients with FL Part 1B and mCRPC Part 1C to determine the monotherapy MTD In Part 2A dose escalation RP2D finding for dose escalation mevrometostat will be administered in combination with SOC to patients with mCRPC and SCLC Japan and China monotherapy cohorts will evaluate the safety antitumor activity and PK of single agent mevrometostat in Japanese and Chinese patients In Part 2B dose expansion patients with mCRPC will be randomized 11 ratio to receive either SOC or mevrometostat in combination with SOC Part 2B will assess the efficacy of mevrometostat at the RP2D in combination with SOC in patients with mCRPC in comparison to SOC alone Part 2C will explore the efficacy of mevrometostat given at a different dosedosing regimen than 2B in combination with SOC in patients with mCRPC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001835-37 | EUDRACT_NUMBER | None | None |