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

Completed · Phase 1

Conditions studied: Breast Cancer, Non-small Lung Cancer

In brief

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 paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.

Key facts

Study ID

NCT01862081

Run by

Genentech, Inc.

People needed

80

Starts

2013-07-16

Expected to finish

2017-06-09

Last updated by the study team

2017-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Cancer Specialists - Tampa (Dr. MLK Blvd) — Tampa, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Oncology, P.A; Baylor Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology, P.A. - Fort Worth — Fort Worth, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Yakima Valley Memorial Hospital/North Star Lodge — Yakima, Washington, United States
• UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy — Leuven, Belgium
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Clinico Universitario de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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