Expanded Access to Veliparib

Triple Negative Breast Cancer (TNBC) Clinical Trial

Official title:

Expanded Access to Veliparib

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03123211
• Other study ID #: C16-468
• Secondary ID: C19-918C20-120
• Status: No longer available

Study information

• Verified date: May 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Description:

Expanded Access

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• High Grade Serous Ovarian Cancer
• Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound
• Triple Negative Breast Cancer (TNBC)
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Veliparib
Veliparib will be administered orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie