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This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ava-mGSIT-P18 | Unresectable or metastatic PDGFRA exon 18 GIST |
| |
| Ava-Perioperative | Perioperative PDGFRA exon 18 GIST |
| |
| Ava-mGIST-other | Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation |
| |
| TKI | Unresectable or metastatic PDGFRA exon 18 GIST |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China |
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| 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. |
|
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000707147 | avapritinib |
| D000068877 | Imatinib Mesylate |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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