A Phase III Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

Clinical Trial Information

Trial Phone: 321-841-7246

Principal Investigator: Tirrell Johnson, MD

Phase: III

Age Group: ADULTOLDER_ADULT

ClinicalTrials.gov ID: NCT05208047

Objective

Primary Outcome Measures: 1. Part 1a - pharmacokinetics - Cmax [Time Frame: 16 days] Maximum plasma concentration (Cmax) 2. Part 1a - pharmacokinetics - AUC [Time Frame: 16 days] Area under the plasma concentration-time curve (AUC) 3. Part 1b - pharmacokinetics - Cmax [Time Frame: 14 days] Maximum plasma concentration (Cmax) 4. Part 1b - pharmacokinetics - AUC [Time Frame: 14 days] Area under the plasma concentration-time curve (AUC) 5. Part 1b - pharmacokinetics - Tmax [ Time Frame: 14 days] Time to maximum observed plasma concentration (Tmax) 6. Part 2 - Progression Free Survival (PFS) [Time Frame: Approximately 48 months] Time from first dose to documented disease progression or death due to any cause, whichever occurs first

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