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Expanded Access to Veliparib

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ClinicalTrials.gov Identifier: NCT03123211
Expanded Access Status : Available
First Posted : April 21, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
Expanded Access

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 Drug: Veliparib

Detailed Description:
Expanded Access

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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



Intervention Details:
  • Drug: Veliparib
    Veliparib will be administered orally.
    Other Name: ABT-188

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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.

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


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03123211     History of Changes
Other Study ID Numbers: C16-468
C19-918 ( Other Grant/Funding Number: AbbVie )
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
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