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A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)

Sponsor
Hutchison Medipharma Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02314819
Collaborator
Fudan University (Other), Eighty-One Hospital of People's Liberation Army (Other)
416
Enrollment
15
Locations
2
Arms
25.6
Duration (Months)
27.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fruquintinib administered at 5mg once daily(QD) in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with metastatic colorectal cancer (CRC) in phase Ib and phase 2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after second line or above standard chemotherapy

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Study Design

Study Type:
Interventional
Actual Enrollment :
416 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind and Placebo-controlled Phase III Trial Comparing Fruquintinib Efficacy and Safety vs Best Support Care (BSC) in Advanced Colorectal Cancer Patients Who Have Failed at Least Second Lines of Chemotherapies
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 17, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: treatment arm

treatment arm- subjects will receive Fruquintinib 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Drug: fruquintinib
fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Other Names:
  • HMPL-013

    		•
    Placebo Comparator: control arm

    control arm- subjects will receive Fruquintinib placebo 5mg orally, QD, plus BSC for 3 wks on/ 1 wk off. Patients will receive a cycles of 4 weeks of study treatment (1 cycle of study treatment includes 3 weeks of treatment and 1 week of drug discontinuation) or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

    Drug: placebo
    fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
    Other Names:
  • HMPL-013 placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [from randomization until death due to any cause, assessed up to 2 year]

      every two months after end of treatment (EOT) observation period at 30 days after the last medication

    Secondary Outcome Measures

    1. progression free survival [from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year]

      Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

    2. Objective Response Rate (ORR) [from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year]

      Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    3. Disease Control Rate (DCR) [from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year]

      Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

    4. Safety and tolerance evaluated by incidence, severity and outcomes of AEs [from first dose to within 30 days after the last dose]

      Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥ 18 and ≤ 75 years of age , with ≥ 40Kg

    • Histological or cytological confirmed colorectal cancer

    • ECOG performance status of 0-1

    • Standard regimen failed or no standard regimen available

    • Adequate hepatic, renal, heart, and hematologic functions

    • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

    • Signed and dated informed consent

    • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

    Exclusion Criteria:
      • Pregnant or lactating women

    • Any factors that influence the usage of oral administration

    • Evidence of CNS metastasis

    • Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure

    • Abuse of alcohol or drugs

    • Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition

    • Disability of serious uncontrolled intercurrence infection

    • Proteinuria ≥ 2+ (1.0g/24hr)

    • Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness

    • Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.

    • Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG

    • Bone fracture or wounds that was not cured for a long time

    • Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hutchison Medi Pharma Investigational Site Hefei Anhui China 230000
    2 Hutchison Medi pharma Investigational Site Beijing Beijing China 100071
    3 Hutchison Medi Pharma Investigational Site Guangzhou Guangdong China 510000
    4 Hutchison Medi Pharma investigational site Shenzhen Guangdong China 518036
    5 Hutchison Medi Pharma Investigational Site Liuzhou Guangxi China 545005
    6 Hutchison Medi Pharma Investigational Site Harbin Heilongjiang China 150081
    7 Hutchison Medi Pharma Investigational Site Changsha Hunan China 410013
    8 Hutchison Medi Pharma Investigational Site Changzhou Jiangsu China 213000
    9 Hutchison Medi Pharma Investigational Site Nanjing Jiangsu China 210000
    10 Hutchison Medi Pharma Investigational Site Nantong Jiangsu China 226000
    11 Hutchison Medi Pharma Investigational Site Xuzhou Jiangsu China 221000
    12 Hutchison Medi Pharma Investigational Site Changchun Jilin China 130000
    13 Hutchison Medi Pharma Investigational Site Qingdao Shandong China 266000
    14 Hutchison Medi Pharma Investigational Site Shanghai Shanghai China 200032
    15 Hutchison Medi Pharma Investigational Site Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • Hutchison Medipharma Limited
    • Fudan University
    • Eighty-One Hospital of People's Liberation Army

    Investigators

    • Principal Investigator: Jin Li, PhD, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hutchison Medipharma Limited
    ClinicalTrials.gov Identifier:
    NCT02314819
    Other Study ID Numbers:
    • 2013-013-00CH1
    First Posted:
    Dec 11, 2014
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2019
    Keywords provided by Hutchison Medipharma Limited
    colorectal cancer
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Feb 17, 2020