Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03343054
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2017-11-11
Brief Title:
A Phase 1 Study Of Talazoparib PARP Inhibitor In Japanese Patients With Advanced Solid Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1 STUDY OF THE SAFETY PHARMACOKINETICS AND ANTI-TUMOR ACTIVITY OF TALAZOPARIB POLY ADP-RIBOSE POLYMERASE PARP INHIBITOR IN JAPANESE PATIENTS WITH ADVANCED SOLID TUMORS
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This is a Phase 1 study which consists of 2 parts Dose Escalation part and Expansion part
The dose escalation part is open-label and evaluates safety preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available
In the dose escalation part up to 18 minimum 3 patients are expected to be enrolled depending on the observed DLTs
The expansion part is designed to assess the efficacy safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations
In the expansion part a minimum of 17 patients will be enrolled evaluable for the primary endpoint
The dose escalation part is open-label and evaluates safety preliminary efficacy and PK of single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available
In the dose escalation part up to 18 minimum 3 patients are expected to be enrolled depending on the observed DLTs
The expansion part is designed to assess the efficacy safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations
In the expansion part a minimum of 17 patients will be enrolled evaluable for the primary endpoint
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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