This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with paclitaxel. Up to approximately 34 patients may be enrolled into the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Vantictumab combined with paclitaxel will be administered IV.
Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
Apparent half life, AUC, clearance, volume of distribution
Time frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56.
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