(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
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Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
482estimated
Sites
126
Countries
Argentina, Australia, Brazil +19
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-04-14 | actual | When the study began enrolling |
| Primary completion | 2025-09-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Gastrointestinal Stromal Tumors
- Metastatic Cancer
Interventions
- Drug: CGT9486 — also filed as Bezuclastinib
- Drug: CGT9486 — also filed as Bezuclastinib
- Drug: Sunitinib
- Drug: Sunitinib
- Drug: Midazolam
- Drug: CGT9486
- Drug: Sunitinib
- Drug: CGT9486 — also filed as Bezuclastinib
- Drug: Sunitinib
Primary outcomes
what the primary-completion date above is the date OFPart 1a - pharmacokinetics - Cmax
measured 16 days
Part 1a - pharmacokinetics - AUC
measured 16 days
Part 1b - pharmacokinetics - Cmax
measured 14 days
Part 1b - pharmacokinetics - AUC
measured 14 days
Part 1b - pharmacokinetics - Tmax
measured 14 days
Part 2 - Progression Free Survival (PFS)
measured Approximately 48 months
DDI Substudy - pharmacokinetics - AUC
measured 16 days
DDI Substudy - pharmacokinetics - Cmax
measured 14 days
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