Overview

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