Expanded Access to Veliparib

AbbVie

Status

Conditions: Triple Negative Breast Cancer (TNBC); Patients Requiring Veliparib Suspension Formulation; Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound; High Grade Serous Ovarian Cancer

Treatments: Drug: Veliparib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03123211

C16-468

C20-120 (Other Grant/Funding Number)

C19-918 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Expanded Access

Sex: All

Volunteers: No Healthy Volunteers

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.