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(Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500637-80-00
Acronym
CGT9486-21-301
Enrollment
114
Registered
2022-09-26
Start date
2023-03-28
Completion date
Unknown
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastrointestinal stromal tumor

Brief summary

Part 2: PFS (defined as the time from randomization to disease progression or death from any cause, whichever occurs first) as determined by BICR using mRECIST v1.1

Detailed description

Part 2 (key sec.): OS, defined as the time from randomization until the date of death, Part 2 (key sec.): ORR, as determined by BICR using mRECIST v1.1

Interventions

DRUGSUNITINIB

Sponsors

Cogent Biosciences Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 2: PFS (defined as the time from randomization to disease progression or death from any cause, whichever occurs first) as determined by BICR using mRECIST v1.1

Secondary

MeasureTime frame
Part 2 (key sec.): OS, defined as the time from randomization until the date of death, Part 2 (key sec.): ORR, as determined by BICR using mRECIST v1.1

Countries

Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026