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

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314819
• Other study ID #: 2013-013-00CH1
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: January 17, 2017

Study information

• Verified date: February 2019
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: January 17, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Hutchison Medi pharma Investigational Site	Beijing	Beijing
China	Hutchison Medi Pharma Investigational Site	Changchun	Jilin
China	Hutchison Medi Pharma Investigational Site	Changsha	Hunan
China	Hutchison Medi Pharma Investigational Site	Changzhou	Jiangsu
China	Hutchison Medi Pharma Investigational Site	Guangzhou	Guangdong
China	Hutchison Medi Pharma Investigational Site	Hangzhou	Zhejiang
China	Hutchison Medi Pharma Investigational Site	Harbin	Heilongjiang
China	Hutchison Medi Pharma Investigational Site	Hefei	Anhui
China	Hutchison Medi Pharma Investigational Site	Liuzhou	Guangxi
China	Hutchison Medi Pharma Investigational Site	Nanjing	Jiangsu
China	Hutchison Medi Pharma Investigational Site	Nantong	Jiangsu
China	Hutchison Medi Pharma Investigational Site	Qingdao	Shandong
China	Hutchison Medi Pharma Investigational Site	Shanghai	Shanghai
China	Hutchison Medi Pharma investigational site	Shenzhen	Guangdong
China	Hutchison Medi Pharma Investigational Site	Xuzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited	Eighty-One Hospital of People's Liberation Army, Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	every two months after end of treatment (EOT) observation period at 30 days after the last medication	from randomization until death due to any cause, assessed up to 2 year
Secondary	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	from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Secondary	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	from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Secondary	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	from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Secondary	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.	from first dose to within 30 days after the last dose