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Clinical Trial VICCBRE1320


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


  • 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


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.


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


Inclusion Criteria:
• Adenocarcinoma of the breast with locally recurrent or metastatic disease
• HER2-negative disease
• Evaluable or measurable disease per 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
Exclusion Criteria:
• Known significant hypersensitivity to any components of study treatment
• Grade >= 2 peripheral neuropathy
• Grade >= 2 hypercholesterolemia or hypertriglyceridemia