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Association details:
Biomarker:BRCA1 mutation
Cancer:Solid Tumor
Drug:veliparib (ABT-888) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer

Excerpt:
...- HER negative with a known germline BRCA1/2 mutation...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors

Excerpt:
...Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator, OR 2) have high grade serous ovarian, fallopian tube, or peritoneal cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Veliparib, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer

Excerpt:
...- Confirmed BRCA1 or BRCA2 mutation associated breast cancer...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase II ABT-888 With Cyclophosphamide

Excerpt:
...- BRCA-positive ovarian cancer (documented deleterious BRCA1/2 mutation or a BRCAPRO score of greater than or equal to 30%)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Expanded Access With ABT-888 (Veliparib) to Treat Metastatic Breast Cancer

Excerpt:
...- Confirmed HER2-, BRCA1 or BRCA2 mutation-associated breast cancer or sporadic triple negative breast cancer....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Excerpt:
...- Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma AND carry a germline mutation in BRCA1 or BRCA2 (confirmation required via Myriad test report); histologic documentation of the original primary tumor is required via the pathology report...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Veliparib, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Cancer

Excerpt:
...- Patients enrolled in stratum II of the study must have BRCA1/2 mutation (added 04/07/09)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation

Excerpt:
...Patients with known germline BRCA1/2 mutations 3....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

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

Excerpt:
...- BRCA1/2 mutation and a BRCA-related malignancy...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Excerpt:
...Prevalence of BRCA1 and BRCA2 Mutations (Somatic or Germline)`Homologous Recombination Deficiency (HRD) Score`Genomic Alterations Identified by the BROCA-homologous Recombinant (HR) Assay...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases

Excerpt:
...previously confirmed deleterious breast cancer 1, early onset (BRCA1) or breast cancer 2, early onset (BRCA2) germline mutation or suspected deleterious BRCA1 or BRCA2 germline mutation if the classification being used is the 5-tier classification; documentation of germline test results are required...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Excerpt:
...- Phase I: Patients must have received at least one prior chemotherapy regimen for metastatic disease; patients with deleterious germ line mutations in breast cancer (BRCA)1 or BRCA2 are...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

ABT-888 and Temozolomide for Metastatic Breast Cancer and BRCA1/2 Breast Cancer

Excerpt:
...To determine Safety and Efficacy in an Expansion Cohort of BRCA1/2 Mutation Carriers....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer

Excerpt:
...- Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Veliparib for the treatment of solid malignancies

Published date:
01/17/2022
Excerpt:
A total of 25 completed clinical trials indicating the use of veliparib in solid malignancies were identified. The results showed that veliparib is well tolerated, both as a single agent and in combination with standard chemotherapy doses....The results from clinical trials indicate that veliparib can be an excellent therapeutic strategy for BRCA mutation associated cancers and tumors bearing deficiencies in the HR pathway as well.
DOI:
10.1177/10781552221073990
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Veliparib for the treatment of solid malignancies

Published date:
01/17/2022
Excerpt:
A total of 25 completed clinical trials indicating the use of veliparib in solid malignancies were identified. The results showed that veliparib is well tolerated, both as a single agent and in combination with standard chemotherapy doses....The results from clinical trials indicate that veliparib can be an excellent therapeutic strategy for BRCA mutation associated cancers and tumors bearing deficiencies in the HR pathway as well.
Secondary therapy:
Chemotherapy
DOI:
10.1177/10781552221073990