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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
fruquintinib
placebo
Sponsored by
Hutchison Medipharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma investigational site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site
  • Hutchison Medi Pharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment arm

control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

progression free survival
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)
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)
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
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.

Full Information

First Posted
December 8, 2014
Last Updated
February 13, 2020
Sponsor
Hutchison Medipharma Limited
Collaborators
Fudan University, Eighty-One Hospital of People's Liberation Army
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1. Study Identification

Unique Protocol Identification Number
NCT02314819
Brief Title
A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients （FRESCO)
Acronym
FRESCO
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 Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hutchison Medipharma Limited
Collaborators
Fudan University, Eighty-One Hospital of People's Liberation Army

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control arm
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
fruquintinib
Other Intervention Name(s)
HMPL-013
Intervention Description
fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
HMPL-013 placebo
Intervention Description
fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Primary Outcome Measure Information:
Title
overall survival
Description
every two months after end of treatment (EOT) observation period at 30 days after the last medication
Time Frame
from randomization until death due to any cause, assessed up to 2 year
Secondary Outcome Measure Information:
Title
progression free survival
Description
Tumor assessment will be performed using radiography method every 8 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1
Time Frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Title
Objective Response Rate (ORR)
Description
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time Frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Title
Disease Control Rate (DCR)
Description
Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Time Frame
from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Title
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
Description
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.
Time Frame
from first dose to within 30 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, PhD, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hutchison Medi Pharma Investigational Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Hutchison Medi pharma Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Hutchison Medi Pharma investigational site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545005
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Hutchison Medi Pharma Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29946728
Citation
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.
Results Reference
result
PubMed Identifier
34408440
Citation
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, Wang N, Zhang B, Zhang Q, Su W, Guo X, Li J. Subgroup Analysis by Liver Metastasis in the FRESCO Trial Comparing Fruquintinib versus Placebo Plus Best Supportive Care in Chinese Patients with Metastatic Colorectal Cancer. Onco Targets Ther. 2021 Aug 11;14:4439-4450. doi: 10.2147/OTT.S307273. eCollection 2021.
Results Reference
derived
PubMed Identifier
33325251
Citation
Xu R, Qin S, Guo W, Bai Y, Deng Y, Yang L, Chen Z, Zhong H, Pan H, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Xu J, Chen D, Li W, Sun S, Yu Z, Cao P, Li J, Chen H, Wang J, Wang S, Wang H, Wang N, Zhang B, Han R, Su W, Guo X, Li J. Subgroup analysis by prior anti-VEGF or anti-EGFR target therapy in FRESCO, a randomized, double-blind, Phase III trial. Future Oncol. 2021 Apr;17(11):1339-1350. doi: 10.2217/fon-2020-0875. Epub 2020 Dec 16.
Results Reference
derived
PubMed Identifier
32901330
Citation
Li J, Guo W, Bai Y, Deng Y, Yang L, Chen Z, Zhong H, Xu R, Pan H, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Xu J, Chen D, Li W, Sun S, Yu Z, Cao P, Shen L, Chen H, Wang S, Wang H, Fan S, Guo X, Wang N, Han R, Zhang B, Qin S. Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial. Adv Ther. 2020 Nov;37(11):4585-4598. doi: 10.1007/s12325-020-01477-w. Epub 2020 Sep 8.
Results Reference
derived

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

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