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

NCT05381753 | Completed

• 1 other identifier: Avapritinib-4-001
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

GIST; Avapritinib

Outcome Measures

Primary Outcomes (2)

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

  AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 3 years.

• Dose adjustment of avapritinib in cohort 1, 2, and 3

  From the start of study drug until 30 days after the last dose, up to 3 years.

Study Arms (4)

Ava-mGSIT-P18

Unresectable or metastatic PDGFRA exon 18 GIST

Drug: Avapritinib

Ava-Perioperative

Perioperative PDGFRA exon 18 GIST

Drug: Avapritinib

Ava-mGIST-other

Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation

Drug: Avapritinib

TKI

Unresectable or metastatic PDGFRA exon 18 GIST

Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )

Interventions

Avapritinib DRUG

Avapritinib will be administered orally at the starting of 300 mg once daily as the label recommended. Investigators can adjust the dosage, frequency, and duration as needed.

Ava-Perioperative; Ava-mGIST-other; Ava-mGSIT-P18

Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al ) DRUG

Investigators will decide which TKI to use as well as the dosage, frequency, and duration.

TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GIST patients with specific genetic mutations who were treated or will be treated with avapritinib (other TKIs in corhort 4) in about 20 hospitals from 1 May 2021 to 31 Aug. 2023.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

avapritinib; Imatinib Mesylate; Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: August 29, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 11, 2026

Record last verified: 2024-11

Locations

CN (1)