Status:
COMPLETED
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 or Non-small Cell Lung Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Breast Cancer, Non-small Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with p...
Eligibility Criteria
Inclusion
- Age \>=18 years
- For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
- For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC
- For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
- Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment
- Evaluable or measurable disease per response evaluation criteria in solid tumors (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
- Use of highly effective form of contraception
Exclusion
- Prior anti-cancer therapy
- Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
- Known significant hypersensitivity to any components of study treatment
- Grade \>=2 peripheral neuropathy
- Type 1 or Type 2 diabetes
- Grade \>=2 hypercholesterolemia or hypertriglyceridemia
- Congenital long QT syndrome
- Active congestive heart failure or ventricular arrhythmia
Key Trial Info
Start Date :
July 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01862081
Start Date
July 16 2013
End Date
June 9 2017
Last Update
November 28 2017
Active Locations (14)
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1
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa, Florida, United States, 33607
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201