Status:
COMPLETED
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01254526
Start Date
December 1 2010
End Date
April 1 2013
Last Update
November 2 2016
Active Locations (3)
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1
Boston, Massachusetts, United States, 02115
2
Nashville, Tennessee, United States, 37203
3
Leuven, Belgium, 3000