This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.
A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy. Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug
University of Southern California-Norris
Los Angeles, California, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Number of participants with response rate as evaluated by RECIST criteria
Time frame: Approximately 12 months
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose
Type of adverse events (AEs)
Time frame: Up to 30 days after last dose
Severity of adverse events (AEs)
Time frame: Up to 30 days after last dose
Duration of response (DOR) calculated for all patients achieving an objective response
Time frame: Approximately 12 months
Progression-free survival (PFS)
Time frame: Approximately 12 months
Overall Survival (OS)
Time frame: Approximately 12 months
Time to peak plasma concentration (Tmax)
Time to peak plasma concentration (Tmax), maximum plasma concentration (Cmax), area under concentration-time curve (AUC)
Time frame: Cycle 1 Day 1 predose and up to 24 hours post dose
Maximum plasma concentration (Cmax)
Time frame: Cycle 1 Day 1 predose and up to 24 hours post dose
Area under concentration-time curve (AUC)
Time frame: Cycle 1 Day 1 predose and up to 24 hours post dose
QTc Interval
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Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, United States
University of Pennsylvania-Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
...and 2 more locations
Time frame: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 of subsequent cycles