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

Genentech

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Treatments

Drug: paclitaxel

Drug: GDC-0980

Drug: bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01254526

PIM4880g

GO00882 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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