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
Completed · Phase 1
Conditions studied: Breast Cancer
In brief
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 facts
- Study ID
- NCT01254526
- Run by
- Genentech, Inc.
- People needed
- 52
- Starts
- 2010-12-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent
- For Arm C: Overexpression of HER2
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate hematologic and organ function
- Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors)
- Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study
You may not qualify if…
- Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer
- Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
- History of Type 1 or Type 2 diabetes requiring regular medication
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Any condition requiring full-dose anticoagulants
- Leptomeningeal disease as a manifestation of cancer
- Active infection requiring IV antibiotics
- Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of <= 10 mg/day of prednisone
- Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
- Known HIV infection
- Known untreated or active CNS metastases
- Pregnancy, lactation, or breastfeeding
- Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment
- For Arm B:
- Uncontrolled hypertension, complication from hypertension, myocardial infarctions, unstable angina, vascular disease or stroke within a specified timeframe of the first dose of study treatment
- Evidence of bleeding diathesis or significant coagulopathy including hemoptysis within a specified timeframe of the first dose of study treatment
- History of abdominal conditions (e.g., fistula, perforation, obstruction) that would preclude use of bevacizumab
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria
Where it is running
- Study site — Boston, Massachusetts, United States
- Study site — Nashville, Tennessee, United States
- Study site — Leuven, Belgium
Full record on ClinicalTrials.gov
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