Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Genentech, Inc.
- Study ID
- NCT01254526
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GDC-0980 — DRUGOral repeating dose
- bevacizumab — DRUGIntravenous repeating dose
- paclitaxel — DRUGIntravenous repeating dose
Study Details
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.
Key Dates
- First listed
- Dec 6, 2010
- Start date
- Dec 31, 2010
- Status verified
- Nov 2016
- Primary completion
- Jul 31, 2012
- Completion
- Apr 30, 2013
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: A
- Experimental: B
Primary Outcome Measure
Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Through Day 22 ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Boston | Massachusetts | 02115 | - |
| - | Nashville | Tennessee | 37203 | - |
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