Colorectal Cancer
Conditions
Keywords
colorectal cancer
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.
Interventions
DRUGfruquintinib
fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
DRUGplacebo
fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
Sponsors
Fudan University
Eighty-One Hospital of People's Liberation Army
Hutchison Medipharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 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
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 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) | 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) | 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 | 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. |
Countries
China
Outcome results
None listed