Breast Cancer Clinical Trial
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
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 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.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There are 14 Locations for this study
Tampa Florida, 33607, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75231, United States
Fort Worth Texas, 76104, United States
Norfolk Virginia, 23502, United States
Yakima Washington, 98902, United States
Leuven , 3000, Belgium
Toronto Ontario, M4X 1, Canada
Barcelona , 08035, Spain
Valencia , 46010, Spain
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