Expanded Access to Veliparib

NCT03123211•AbbVie

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

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Key Dates

Last Updated

May 24, 2022

Conditions

Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically SoundTriple Negative Breast Cancer (TNBC)High Grade Serous Ovarian CancerPatients Requiring Veliparib Suspension Formulation

Interventions

Veliparib

DRUG

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

View study

RECRUITINGPHASE1

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

NCT07029399

HR+ Breast CancerTriple Negative Breast Cancer (TNBC)+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expanded Access to Veliparib

Inclusion Criteria

Exclusion Criteria

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4

A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib