GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
177
15 Minute IV Infusion
15 Minute IV Infusion
Overall Survival
Overall survival is defined as the time from randomization to the date of death from any cause. The number of subjects that have died during this time period is the reported outcome measure.
Time frame: From randomization of the first subject until 30 days post last dose of GC4711/ and SBRT for the last subject randomized to the study (total duration 2years and 6.5 months)
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