Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments fruquintinib, placebo
Phase phase 3
Target VEGF
Sponsor Hutchison Medipharma Limited
Collaborator Fudan University
Start date December 2014
End date March 2017
Trial size 416 participants
Trial identifier NCT02314819, 2013-013-00CH1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
fruquintinib HMPL-013
fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
(Placebo Comparator)
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.
placebo HMPL-013 placebo
fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off

Primary Outcomes

Measure
overall survival
time frame: from randomization until death due to any cause, assessed up to 2 year

Secondary Outcomes

Measure
progression free survival
time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Objective Response Rate (ORR)
time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Disease Control Rate (DCR)
time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
time frame: from first dose to within 30 days after the last dose

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hutchison Medipharma Limited.