Expanded Access to Veliparib

Study Identifier
C16-468
CT.gov Identifier
NCT03123211
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Solid Tumors (General)
  • Breast Cancer
  • Ovarian Cancer
  • Cancer - Other
    • Study Drug
  • Veliparib
    • Phase
    N/A
    Sex
    Female & Male
    Age
    N/A
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    No locations found.