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 — DRUGPatients 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 — DRUGCisplatin will be administered intravenously (75 mg/m2) on Day 1 of each cycle
- Vinorelbine — DRUGVinorelbine 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Seattle Cancer Care Allliance | Seattle | Washington | 98109 | - |
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