Clinical Trial 19455

Cancer Type:
Interventions:CB-839; Taxol (paclitaxel); paclitaxel

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Hatem Soliman

Overview

Study Title

A Multicenter Phase 2 Study of the Glutaminase Inhibitor CB-839 in Combination with Paclitaxel in Patients with Advanced Triple Negative Breast Cancer (TNBC) Including Patients of African Ancestry and Non-African Ancestry

Summary

The purpose of this study is to determine if CB-839 (an investigational drug), given together with paclitaxel (an approved drug) has an effect on this type of cancer.

Objective

To evaluate the overall response rate (ORR) of patients treated with CB-839 plus paclitaxel (Pac-CB) for metastatic TNBC. Secondary Objectives: To evaluate the progression free survival (PFS) of patients treated with CB-839 plus paclitaxel (Pac-CB) for metastatic TNBC. To evaluate the overall survival (OS) of patients treated with CB-839 plus paclitaxel (Pac-CB) for metastatic TNBC. To evaluate duration of response (DOR) of patients treated with CB-839 plus paclitaxel (Pac-CB) for metastatic TNBC. To evaluate clinical benefit rate (CBR) of patients treated with CB-839 plus paclitaxel (Pac-CB) for metastatic TNBC.

Inclusion Criteria

  • Meets criteria for 1 of the 4 defined study cohorts.
  • Triple Negative Breast Cancer (TNBC) defined as ER and PR negative (> Metastatic disease or locally-advanced disease not amenable to curative intent treatment.
  • Adequate hepatic, renal, cardiac, and hematologic function.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Recovery to baseline or ≤ Grade 1 NCI Common Terminology Criteria for Adverse Events (CTCAE) ver.4.0.

  • Exclusion Criteria

  • Known brain metastases or central nervous system (CNS) cancer unless adequately treated with radiotherapy and/or surgery and stable for ≥ 2 months.
  • Unable to receive oral medications.
  • Known hypersensitivity to Cremophor®-based agents.
  • Major surgery within 28 days of Cycle 1 Day 1 (C1D1).