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Expanded Access to Veliparib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03123211
Expanded Access Status : No longer available
First Posted : April 21, 2017
Last Update Posted : May 24, 2022
Information provided by (Responsible Party):

Tracking Information
First Submitted Date April 18, 2017
First Posted Date April 21, 2017
Last Update Posted Date May 24, 2022
Descriptive Information
Brief Title Expanded Access to Veliparib
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
Study Type Expanded Access
Expanded Access Type 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
  • Patients Requiring Veliparib Suspension Formulation
Intervention Drug: Veliparib
Veliparib will be administered orally.
Other Name: ABT-888
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status No longer available
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.
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03123211
Other Study ID Numbers C16-468
C19-918 ( Other Grant/Funding Number: AbbVie )
C20-120 ( Other Grant/Funding Number: AbbVie )
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor AbbVie
Original Study Sponsor Same as current
Collaborators Not Provided
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date May 2022