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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT02985658
Status
No Longer Available

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Veliparib — DRUG
    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
  • Cisplatin — DRUG
    Cisplatin will be administered intravenously (75 mg/m2) on Day 1 of each cycle
  • Vinorelbine — DRUG
    Vinorelbine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle

Study Details

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.

Key Dates

Status verified
Jul 2021

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Cancer Care AlllianceSeattleWashington98109-

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