Pancreatic Cancer - ABT-888 - BRCA1 mutation

Association details:

Biomarker:	BRCA1 mutation
Cancer:	Pancreatic Cancer
Drug:	veliparib (ABT-888) (PARP inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer

Excerpt:

...- Personal or known family history of a deleterious (or indeterminate) mutation in the BRCA1, BRCA2, PALBB2, or one of the FANC genes....

Trial ID:

NCT01489865

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors

Excerpt:

...- BRCA1/2 mutation and a BRCA-related malignancy...

Trial ID:

NCT01233505

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer

Excerpt:

...- Patients with known or suspected germline mutation in BRCA1 or BRCA2 are eligible to participate...

Trial ID:

NCT01282333

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Excerpt:

...- Male or female patients with cytologically or histologically confirmed locally advanced or metastatic pancreas adenocarcinoma with a BRCA1 or 2 or PALB2 mutation confirmed by report from Myriad Genetics (United States of America [USA]); reports from other molecular diagnostic companies can be used to confirm mutations as well; BRCA 1 or 2 or PALB2 mutation can be confirmed locally for all international sites...

Trial ID:

NCT01585805

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Veliparib in Treating Patients With Malignant Solid Tumors That Do Not Respond to Previous Therapy

Excerpt:

...- Have a documented BRCA1/2 mutation and a BRCA related malignancy (primarily breast or ovarian cancers, but also may include prostate or pancreatic cancers);...

Trial ID:

NCT00892736

Evidence Level:

Sensitive: C3 – Early Trials

Source:

ASCO-GI 2020

Title:

A randomized, multicenter, phase II trial of gemcitabine (G), cisplatin (C) +/- veliparib (V) in patients with pancreas adenocarcinoma (PDAC) and a known germline (g)BRCA/ PALB2 mutation.

Published date:

03/24/2020

Excerpt:

Exploratory analyses (combined Arms): Med OS if > 4 m platinum → PARPi: 23 m (95%CI 6.5- 53.9). Med OS by BRCA: BRCA1: 14 m (8.1- 18.5); BRCA2: 20.2 m (12.3- 24.4)...GC +/- V very active in gBRCA/PALB2 mut PDAC with high RR, PFS, OS with both A, B significantly exceeding threshold RR.

Secondary therapy:

cisplatin + gemcitabine

Trial ID:

NCT01585805

Evidence Level:

Sensitive: C3 – Early Trials

Source:

Cancer

Title:

Phase 1 trial evaluating cisplatin, gemcitabine, and veliparib in 2 patient cohorts: Germline BRCA mutation carriers and wild-type BRCA pancreatic ductal adenocarcinoma

Excerpt:

The objective response rate in the BRCA+ cohort was 7 of 9 (77.8%). The median overall survival for BRCA+ patients was 23.3 months (95% confidence interval [CI], 3.8-30.2 months).

DOI:

10.1002/cncr.31218

Trial ID:

NCT01585805