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Expanded Access With ABT-888 (Veliparib) to Treat Metastatic Breast Cancer

NCT02985658 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-07-21

No results posted yet for this study

Summary

This is an expanded access protocol to allow continued maintenance therapy with ABT-888 (veliparib) for three patients with metastatic triple negative breast cancer who are currently receiving the investigational product in association with clinical trial participation. Additionally, the protocol will enroll up to 7 new patients with metastatic BRCA associated or triple negative breast cancer to allow for additional access to veliparib monotherapy, or at the investigator's discretion, veliparib in combination with cisplatin and/or vinorelbine.

Conditions

  • Metastatic Breast Cancer With BRCA 1 or BRCA 2 Genetic Mutation
  • Triple-Negative Breast Cancer

Interventions

DRUG

Veliparib

Patients will start veliparib at 300 mg po BID days 1 through 21 of the first 21 day cycle, then increase to 400 mg po BID days 1 through 21 of each subsequent cycle, as tolerated by the patient. At the treating investigator's discretion, and with principal investigator approval, veliparib may be used in combination with cisplatin and/or vinorelbine. Veliparib (300mg) will be dosed po BID on Days 1 through 14 of each 21-day cycle. The patient will receive therapy as long as there is therapeutic benefit

DRUG

Cisplatin

Cisplatin will be administered intravenously (75 mg/m2) on Day 1 of each cycle

DRUG

Vinorelbine

Vinorelbine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985658 on ClinicalTrials.gov