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Study of Elunate® (Fruquintinib) in Chinese Patients With Advanced CRC

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ClinicalTrials.gov Identifier: NCT04005066
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Description
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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
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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
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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
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Primary Outcome Measures :
  1. Incidence of AEs [ Time Frame: from the first administration of fruquintinib up to 6 months ]
    % of patients with AEs according to CTCAE 4.03

  2. Incidence of ADRs [ Time Frame: from the first administration of fruquintinib up to 6 months ]
    % of patients with ADRs according to CTCAE 4.03

  3. 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

  4. 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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005066


Contacts
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Contact: Xijie Zhang 86-020-37874391 xijiez@hmplglobal.com
Contact: Qiao Yan 86-021-20673225 qiaoy@hmplglobal.com

Locations
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China
Shanghai Dongfang Hospital Recruiting
Shanghai, China
Contact: Jin Li, PH.D         
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Study Director: Xijie Zhang Hutchison Medipharma Limited
More Information
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04005066    
Other Study ID Numbers: 2018-013-00CH2
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases