Study of Fruquintinib in Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Fruquintinib, 013
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 and ≤ 75 years of age , with ≥ 40 Kg
- Histological or cytological confirmed metastatic colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Failed 2 or more lines of chemotherapy
- 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
- Central nervous system (CNS) metastasis
- One of the following conditions: 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)
- Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
- History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
- History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months
- 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
- Hutchison Medi Pharma Investigational Site
- Hutchison Medi Pharma Investigational Site
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
treatment arm
control arm
treatment arm- subjects will receive Fruquintinib 5mg orally, once daily (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, once daily (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.