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A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients
This study is a prospective, open-label, multi-center, study design to obtain the safety information of participant after medication. The follow-up time points for each participant include first time signing the informed consent form,1 month after signing the informed consent form, 6 months after signing the informed consent form or 30 days after the last dose (whichever occurs first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elunate® | Drug | The recommended dose is 5 mg once daily (1 capsule, each capsule contains 5 mg of fruquintinib); three weeks of continuous drug administration followed by one week of drug free period (4 weeks as one treatment cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | % of patients with AEs according to CTCAE 4.03 | from the first administration of fruquintinib up to 6 months |
| Incidence of ADRs | % of patients with ADRs according to CTCAE 4.03 | from the first administration of fruquintinib up to 6 months |
| Incidence of SAEs | % of patients with SAEs according to CTC AE 4.03 | from the first administration of fruquintinib up to 6 months |
| Incidence of AESI | % of patients with AESI according to CTC AE 4.03 | from the first administration of fruquintinib up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
• Unsuitable for the study according to investigator's judgement.
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Advanced solid tumor patients treated with Elunate®( fruquintinib) in Chinese real world practice
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| Name | Affiliation | Role |
|---|---|---|
| Mandy Xue | Hutchmed | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dongfang Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
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