This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.
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 docetaxel. Up to approximately 34 patients may be enrolled into the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Docetaxel will be administered IV.
Vantictumab will be administered intravenously
University of Colorado
Aurora, Colorado, United States
Roswell Park Cancer Center, Elm & Carlton Streets
Buffalo, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Safety and tolerability of vantictumab in combination with docetaxel in patients with recurrent or advanced NSCLC. The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly paclitaxel.
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
Pharmacokinetics (PK) of vantictumab when administered in combination with docetaxel to patients with recurrent or advanced NSCLC
Apparent half life, AUC, clearance, volume of distribution
Time frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion and before docetaxel infusion from Day 0 to treatment termination
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