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
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.
Checked against the public recordLast updated Nov 28, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: Docetaxel; Drug: GDC-0032; Drug: Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Florida Cancer Specialists - Tampa (Dr. MLK Blvd)Tampa, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
- Sarah Cannon Research InstituteNashville, Tennessee
- Vanderbilt University Medical CenterNashville, Tennessee
- Texas Oncology, P.A; Baylor Sammons Cancer CenterDallas, Texas
- Texas Oncology, P.A. - Fort WorthFort Worth, Texas
- Virginia Oncology AssociatesNorfolk, Virginia
- Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington
- UZ Leuven; Maag, -darm en leverziekten/endoscopie - EndoscopyLeuven
- Princess Margaret HospitalToronto, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 28, 2017. Always confirm current availability with the study team.