Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World
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 |
---|---|---|
|
Study Design
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
- 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.]
Eligibility Criteria
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
- 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.- Avapritinib-4-001