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Expanded Access to Veliparib

Expanded Access to Veliparib

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Expanded Access

Conditions

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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 Patients Requiring Veliparib Suspension Formulation

Interventions

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Veliparib

Veliparib will be administered orally.

Intervention Type DRUG

Other Intervention Names

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ABT-888

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers