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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 : November 8, 2017
Sponsor:
Collaborators:
Fudan University
Eighty-One Hospital of People's Liberation Army
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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
Colorectal Cancer Drug: fruquintinib Drug: placebo 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 Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: HMPL-013 placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02314819


Locations
China, Anhui
Hutchison Medi Pharma Investigational Site
Hefei, Anhui, China, 230000
China, Beijing
Hutchison Medi pharma Investigational Site
Beijing, Beijing, China, 100071
China, Guangdong
Hutchison Medi Pharma Investigational Site
Guangzhou, Guangdong, China, 510000
Hutchison Medi Pharma investigational site
Shenzhen, Guangdong, China, 518036
China, Guangxi
Hutchison Medi Pharma Investigational Site
Liuzhou, Guangxi, China, 545005
China, Heilongjiang
Hutchison Medi Pharma Investigational Site
Harbin, Heilongjiang, China, 150081
China, Hunan
Hutchison Medi Pharma Investigational Site
Changsha, Hunan, China, 410013
China, Jiangsu
Hutchison Medi Pharma Investigational Site
Changzhou, Jiangsu, China, 213000
Hutchison Medi Pharma Investigational Site
Nanjing, Jiangsu, China, 210000
Hutchison Medi Pharma Investigational Site
Nantong, Jiangsu, China, 226000
Hutchison Medi Pharma Investigational Site
Xuzhou, Jiangsu, China, 221000
China, Jilin
Hutchison Medi Pharma Investigational Site
Changchun, Jilin, China, 130000
China, Shandong
Hutchison Medi Pharma Investigational Site
Qingdao, Shandong, China, 266000
China, Shanghai
Hutchison Medi Pharma Investigational Site
Shanghai, Shanghai, China, 200032
China, Zhejiang
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02314819     History of Changes
Other Study ID Numbers: 2013-013-00CH1
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Hutchison Medipharma Limited:
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases