High Grade Serous Ovarian Cancer, Patients Requiring Veliparib Suspension Formulation, Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound, Triple Negative Breast Cancer (TNBC)
Conditions
Keywords
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
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
Interventions
DRUGVeliparib
Veliparib will be administered orally.
Sponsors
AbbVie
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Outcome results
None listed