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TH-302 Dose escalation for Gastrointestinal Stromal Tumors (TH-CR-410 Trial)
Summary
The primary objectives are: Dose escalation: 1. To determine the MTD and DLT(s) of TH-302 when used in combination with sunitinib. Dose expansion: 1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by the response rate and the progression-free survival in subjects with advanced RCC treated at the RP2D 2. To assess the safety of TH-302 in combination with sunitinib and determine a recommended Phase 2 dose of the combination. The secondary objectives are: Dose expansion: 1. To make a preliminary assessment of the efficacy of TH-302 in combination with sunitinib as determined by stable disease or better rate, duration of response and overall survival in subjects with advanced RCC treated at the RP2D. The exploratory objective is: 1. To explore the association of serum hypoxia biomarkers with efficacy endpoints.
- Gastrointestinal Stromal Tumors
- Kidney Cancer
- Pancreatic Neuroendocrine Tumors
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From 2016 Phase 3 trial • 693 Patients • NCT01746979Trial Design
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