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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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 patients with locally recurrent or metastatic breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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