Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02401347
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2015-03-24
Brief Title:
Phase II Trial of Talazoparib in BRCA12 Wild-type HER2-negative Breast Cancer and Other Solid Tumors
Sponsor:
Melinda Telli
Organization:
Stanford University
Study Overview
Official Title:
A Phase II Clinical Trial of the PARP Inhibitor Talazoparib in BRCA1 and BRCA2 Wild Type Patients With Advanced Triple Negative Breast Cancer and Homologous Recombination Deficiency or Advanced HER2 Negative Breast Cancer or Other Solid Tumors With a Mutation in Homologous Recombination Pathway Genes
Status:
COMPLETED
Status Verified Date:
2023-02
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:
The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of Talazoparib also known as BMN 673 in patients with advanced breast cancer with specific genetic or tumor genomic alterations Patients with either triple-negative or HER2-negative breast cancer are eligible
Detailed Description:
Talazoparib BMN 673 is a novel dual-mechanism PARP inhibitor that potently inhibits the PARP enzyme and effectively traps PARP on DNA Talazoparib has shown promising single-agent anti-tumor efficacy in several BRCA12 mutation-associated advanced cancers The efficacy of PARP inhibition in BRCA12 wild-type TNBC with homologous recombination HR defects and in breast tumors with mutations in other non-BRCA12 HR pathway genes is currently unknown
This phase 2 trial explores the activity of single agent talazoparib in BRCA12 wild-type BC patients using an optimal Simon two-stage design Eligible subjects will be assigned to one of two parallel cohorts 1 Cohort A Subjects n29 with advanced TNBC with underlying HR defects as assessed by the HRD assay and 2 Cohort B Subjects n29 with advanced HER2-negative BC with a somatic or germline mutation in a non-BRCA12 HR pathway gene Gene mutations of interest are PTEN PALB2 CHEK2 ATM NBN BARD1 BRIP1 RAD50 RAD51C RAD51D MRE11 ATR Fanconi anemia complementation group of genes FANCA FANCC FANCD2 FANCE FANCF FANCG FANCL
This phase 2 trial explores the activity of single agent talazoparib in BRCA12 wild-type BC patients using an optimal Simon two-stage design Eligible subjects will be assigned to one of two parallel cohorts 1 Cohort A Subjects n29 with advanced TNBC with underlying HR defects as assessed by the HRD assay and 2 Cohort B Subjects n29 with advanced HER2-negative BC with a somatic or germline mutation in a non-BRCA12 HR pathway gene Gene mutations of interest are PTEN PALB2 CHEK2 ATM NBN BARD1 BRIP1 RAD50 RAD51C RAD51D MRE11 ATR Fanconi anemia complementation group of genes FANCA FANCC FANCD2 FANCE FANCF FANCG FANCL
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 |
|---|---|---|---|
| NCI-2015-00036 | REGISTRY | None | None |
| BRS0050 | OTHER | OnCore | None |