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

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Gastrointestinal Stromal Tumors
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Stromal Tumor Open-label Trial of GlivecWith Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors Role of Surgery in Patients With Focally Progressive Gastrointestinal Stromal Tumors (GISTs) After Imatinib Treatment WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST) Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001 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Brief Title

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

Official Title

A National Multicenter, Noninterventional Clinical Study Evaluating the Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

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.

Study Type

Observational

Primary Outcome

Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3

Condition

Gastrointestinal Stromal Tumors

Intervention

Avapritinib

Study Arms / Comparison Groups

 Ava-mGSIT-P18
Description:  Unresectable or metastatic PDGFRA exon 18 GIST

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

200

Start Date

July 2022

Completion Date

October 2025

Primary Completion Date

May 2025

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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.

Gender

All

Ages

18 Years - N/A

Contacts

, + 86-(0)21-6033-5000, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT05381753

Organization ID

Avapritinib-4-001

Responsible Party

Sponsor

Study Sponsor

CStone Pharmaceuticals

Study Sponsor

, ,

Verification Date

May 2022