A Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: GDC-0032 Type: Drug
Name: GDC-0032 Type: Drug
Name: Docetaxel Type: Drug
Name: Paclitaxel Type: Drug
Overall Status
Recruiting
Summary
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered in combinat ion with either docetaxel (Arm A) or with paclitaxel (Arm B) in patients with HE R2-negative locally recurrent or metastatic breast cancer. Stage 1: Both Arms A and B will employ a dose-escalation design with escalating doses of GDC-0032.

Once the maximum tolerated dose of GDC-0032 has been established, additional pa tients will be enrolled in the cohort-expansion stage (Stage 2).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Locations
Tampa, Florida, United States
Status: Recruiting
Boston, Massachusetts, United States
Status: Recruiting
Boston, Massachusetts, United States
Status: Recruiting
Detroit, Michigan, United States
Status: Recruiting
Albany, New York, United States
Status: Not yet recruiting
Nashville, Tennessee, United States
Status: Recruiting
Nashville, Tennessee, United States
Status: Recruiting
Dallas, Texas, United States
Status: Recruiting
Fort Worth, Texas, United States
Status: Recruiting
Norfolk, Virginia, United States
Status: Not yet recruiting
Yakima, Washington, United States
Status: Not yet recruiting
Start Date
August 2013
Completion Date
January 2016
Sponsors
Genentech, Inc.
Source
Genentech, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page