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
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:December 2010
End Date:April 2013

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A Phase Ib, Open-Label, Dose-Escalation 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

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.


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
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