NCT03123211

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

First QC Date

April 18, 2017

Last Update Submit

May 20, 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

Keywords

Expanded AccessPre-approval AccessCompassionate UseSpecial Access ProgramNamed Patient BasisSpecial Access Scheme

Interventions

VeliparibDRUG

Veliparib will be administered orally.

Also known as: ABT-888

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

veliparib

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 21, 2017

Last Updated

May 24, 2022

Record last verified: 2022-05