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

• Status: Completed
• Trial end date: 2017-06-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Paclitaxel

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