Official Title
Expanded Access to Veliparib
Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to veliparib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. EAP is also available for other indications where there is reasonable scientific basis for efficacy.

Detailed Description

Expanded Access

Individual Patients
Intermediate-size Population
Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound
Triple Negative Breast Cancer (TNBC)
High Grade Serous Ovarian Cancer

Drug: Veliparib
Veliparib will be administered orally.
Other Name: ABT-888

Eligibility Criteria

Inclusion Criteria: - The patient has relapsed/refractory disease and exhausted all standard treatments. - The patient has documented Breast Cancer (BRCA), BRCA associated RING domain (BARD), or Partner and Localizer of Breast Cancer (PALB) or other acceptable deoxyribonucleic acid (DNA) mutations.

Exclusion Criteria: - The patient is eligible for a Poly Adenosine diphosphate ribose polymerase (PARP) inhibitor clinical trial. - The patient has previously received a PARP inhibitor for the same disease.

Eligibility Gender


AbbVie Inc.
Study Director

NCT Number
Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
MeSH Terms
Triple Negative Breast Neoplasms
Intervention Name