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Clinical Trial VICCBRE1320

Title

A Phase Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0032 in Combination with Either Docetaxel or Paclitaxel in Patients with HER2-Negative Locally Recurrent or Metastatic Breast Cancer or Non-Small Cell Lung Cancer

Principal Investigator(s)

Vandana Abramson

Details

  • Protocol No. VICCBRE1320
  • Open Date: 08/16/2013
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objectives of the study are as follows: - To evaluate the safety and tolerability of GDC-0032 administered in combination with docetaxel or paclitaxel - To identify DLTs and estimate the MTD of GDC-0032 in combination with docetaxel or paclitaxel - To identify a recommended dose for future studies for GDC-0032 in combination with docetaxel or paclitaxel
  • Disease Sites: Breast
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Docetaxel; Docetaxel (Taxotere); GDC-0032(taselisib); Paclitaxel
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01862081
  • Secondary Protocol No: GO27802

Description

The purpose of this study is to find out whether an experimental drug (GDC 0032) can be safely combined with paclitaxel (Taxol), or docetaxel (Taxotere), to determine a safe and tolerated dose, how often it should be taken, how well patients with cancer can tolerate this experimental drug in combination with chemotherapy, and to measure how the body processes the study drug at different dose levels.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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