A Phase Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0032 in Combination With Either Docetaxel or Paclitaxel in Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Phase Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0032 in Combination With Either Docetaxel or Paclitaxel in Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Inclusion Criteria:
- Adenocarcinoma of the breast with locally recurrent or metastatic disease
- HER2-negative disease
- Evaluable or measurable disease per RECIST v.1.1
- Life expectancy >= 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening
- Adequate hematologic and end organ function
Exclusion Criteria:
- Known significant hypersensitivity to any components of study treatment
- Grade >= 2 peripheral neuropathy
- Grade >= 2 hypercholesterolemia or hypertriglyceridemia
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: Incidence of adverse events
Outcome Time Frame:
Approximately 3 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Genentech
Authority:
United States: Food and Drug Administration
Study ID:
GO27802
NCT ID:
NCT01862081
Start Date:
April 2013
Completion Date:
January 2016
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| McLean, Virginia 22101 | |
| Boston, Massachusetts |
