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出境医 / 临床实验 / Study of Elunate® (Fruquintinib) in Chinese Patients With Advanced CRC
Study of Elunate® (Fruquintinib) in Chinese Patients With Advanced CRC
Study Description
Brief Summary:
A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Colorectal Cancer | Drug: Elunate® | Phase 4 |
Detailed Description:
This is a prospective, multicenter, double-cohort, phase IV study, to evaluate safety of Elunate® (Fruquintinib) in Chinese patients. There're 3 visits, including signing the ICF, 1 month after signing the ICF, 6 months after signing the ICF or 30 days after the last day of treatment. Patients who are using Elunate® or plan to use Elunate® within 1 week could be enrolled to this study. There're 2 cohorts for this study as below:
Cohort 1: metastatic colorectal cancer patients who are in accordance with Elunate® package insert, the sample size is 2000; Cohort 2: other patients suitable for treatment with Elunate® according to investigator's judgement, the sample size is 1000.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3000 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Cohort 1: metastatic colorectal cancer patients who are accordance with Elunate® package insert, the sample size is 2000; Cohort 2: other patients suitable for according to investigator's judgement, the sample size is 1000. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Double-cohort, Multi-center, Phase IV Study to Further Characterize |
| Actual Study Start Date : | April 20, 2019 |
| Estimated Primary Completion Date : | November 30, 2022 |
| Estimated Study Completion Date : | February 28, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Cohort 1
metastatic colorectal cancer patients who are accordance with Elunate® package insert
|
Drug: Elunate®
Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days
Other Name: Fruquintinib
|
|
Cohort 2
other patients suitable for according to investigator's judgement
|
Drug: Elunate®
Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days
Other Name: Fruquintinib
|
Outcome Measures
Primary Outcome Measures :
- Incidence of AEs [ Time Frame: from the first administration of fruquintinib up to 6 months ]% of patients with AEs according to CTCAE 4.03
- Incidence of ADRs [ Time Frame: from the first administration of fruquintinib up to 6 months ]% of patients with ADRs according to CTCAE 4.03
- Incidence of SAEs [ Time Frame: from the first administration of fruquintinib up to 6 months ]% of patients with SAEs according to CTC AE 4.03
- Incidence of AESI [ Time Frame: from the first administration of fruquintinib up to 6 months ]% of patients with AESI according to CTC AE 4.03
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Basic inclusion criteria for both cohort 1&cohort 2:
- Currently using Elunate® or will use Elunate® within a week;
- Provision of informed consent by the patient.
Cohort 1: Besides 2 criteria above, there're 3 more inclusion criteria for Cohort 1:
- Diagnosed metastatic colorectal cancer;
- ECOG PS ≤2 (0-2)；
- Patients are suitable to use Elunate® according to investigator's judgement. Cohort 2: Patients only meet 2 basic inclusion criteria and suitable to use Elunate® according to investigator's judgement could be enrolled in cohort 2.
Exclusion Criteria:
-
Exclusion criteria for both cohort 1& cohort 2:
- Unsuitable for the experiment according to investigator's judgement.
Contacts and Locations
Contacts
| Contact: Xijie Zhang | 86-020-37874391 | xijiez@hmplglobal.com | |
| Contact: Qiao Yan | 86-021-20673225 | qiaoy@hmplglobal.com |
Locations
| China | |
| Shanghai Dongfang Hospital | Recruiting |
| Shanghai, China | |
| Contact: Jin Li, PH.D | |
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
| Study Director: | Xijie Zhang | Hutchison Medipharma Limited |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 18, 2019 | ||||||||
| First Posted Date ICMJE | July 2, 2019 | ||||||||
| Last Update Posted Date | June 9, 2020 | ||||||||
| Actual Study Start Date ICMJE | April 20, 2019 | ||||||||
| Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Elunate® (Fruquintinib) in Chinese Patients With Advanced CRC | ||||||||
| Official Title ICMJE | A Prospective, Double-cohort, Multi-center, Phase IV Study to Further Characterize | ||||||||
| Brief Summary | A phase IV study to characterize safety of Elunate® (Fruquintinib) in Chinese patients | ||||||||
| Detailed Description |
This is a prospective, multicenter, double-cohort, phase IV study, to evaluate safety of Elunate® (Fruquintinib) in Chinese patients. There're 3 visits, including signing the ICF, 1 month after signing the ICF, 6 months after signing the ICF or 30 days after the last day of treatment. Patients who are using Elunate® or plan to use Elunate® within 1 week could be enrolled to this study. There're 2 cohorts for this study as below: Cohort 1: metastatic colorectal cancer patients who are in accordance with Elunate® package insert, the sample size is 2000; Cohort 2: other patients suitable for treatment with Elunate® according to investigator's judgement, the sample size is 1000. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: Cohort 1: metastatic colorectal cancer patients who are accordance with Elunate® package insert, the sample size is 2000; Cohort 2: other patients suitable for according to investigator's judgement, the sample size is 1000. Masking: None (Open Label)Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Advanced Colorectal Cancer | ||||||||
| Intervention ICMJE | Drug: Elunate®
Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days
Other Name: Fruquintinib
|
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| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
3000 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | February 28, 2023 | ||||||||
| Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Cohort 1: Besides 2 criteria above, there're 3 more inclusion criteria for Cohort 1:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04005066 | ||||||||
| Other Study ID Numbers ICMJE | 2018-013-00CH2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Hutchison Medipharma Limited | ||||||||
| Study Sponsor ICMJE | Hutchison Medipharma Limited | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | Hutchison Medipharma Limited | ||||||||
| Verification Date | June 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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