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

Sponsor
CStone Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05381753
Collaborator
(none)
200
1
39
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Avapritinib
  • Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Other
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Ava-mGSIT-P18

Unresectable or metastatic PDGFRA exon 18 GIST

Drug: Avapritinib
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

Perioperative PDGFRA exon 18 GIST

Drug: Avapritinib
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-mGIST-other

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

Drug: Avapritinib
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.

TKI

Unresectable or metastatic PDGFRA exon 18 GIST

Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )
Investigators will decide which TKI to use as well as the dosage, frequency, and duration.

Outcome Measures

Primary Outcome Measures

  1. 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.]

  2. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

  1. treatment assessed by researchers.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100000

Sponsors and Collaborators

  • CStone Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CStone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05381753
Other Study ID Numbers:
  • Avapritinib-4-001
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Keywords provided by CStone Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2022