Status:

COMPLETED

Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

Lead Sponsor:

CStone Pharmaceuticals

Conditions:

Gastrointestinal Stromal Tumors

Eligibility:

All Genders

18+ years

Brief Summary

This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.

Eligibility Criteria

Inclusion

  • Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon 18.
  • Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting.
  • Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRα gene exon 18, KIT gene exon 13, and KIT gene exon 14.

Exclusion

  • Participants who have participated and may participate in any other interventional clinical trail in the future.
  • Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.

Key Trial Info

Start Date :

August 29 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 30 2024

Estimated Enrollment :

61 Patients enrolled

Trial Details

Trial ID

NCT05381753

Start Date

August 29 2022

End Date

September 30 2024

Last Update

November 13 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100000