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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
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment
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 Drug: Veliparib

Detailed Description:
Expanded Access
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients, Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Veliparib

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Veliparib
    Veliparib will be administered orally.
    Other Name: ABT-888
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123211


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123211    
Other Study ID Numbers: C16-468
C19-918 ( Other Grant/Funding Number: AbbVie )
C20-120 ( Other Grant/Funding Number: AbbVie )
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
 Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Neoplasms
Breast Diseases
Skin Diseases
 Veliparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents