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 |
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.
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
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials