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

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ClinicalTrials.gov Identifier: NCT02314819
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Fudan University
Eighty-One Hospital of People's Liberation Army
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Tracking Information
First Submitted Date  ICMJE December 8, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
overall survival [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02314819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • progression free survival [ Time Frame: 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
  • Objective Response Rate (ORR) [ Time Frame: 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
  • Disease Control Rate (DCR) [ Time Frame: 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
  • Safety and tolerance evaluated by incidence, severity and outcomes of AEs [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients (FRESCO)
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: fruquintinib
    fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
    Other Name: HMPL-013
  • Drug: placebo
    fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
    Other Name: HMPL-013 placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: fruquintinib
  • 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.
    Intervention: Drug: placebo
Publications * Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2016)
416
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2014)
400
Actual Study Completion Date  ICMJE January 17, 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314819
Other Study ID Numbers  ICMJE 2013-013-00CH1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hutchison Medipharma Limited
Study Sponsor  ICMJE Hutchison Medipharma Limited
Collaborators  ICMJE
  • Fudan University
  • Eighty-One Hospital of People's Liberation Army
Investigators  ICMJE
Principal Investigator: Jin Li, PhD, MD Fudan University
PRS Account Hutchison Medipharma Limited
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP