Status:
COMPLETED
Study of Fruquintinib in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Hutchison Medipharma Limited
Collaborating Sponsors:
Fudan University
Sun Yat-sen University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in pati...
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC i...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT02196688
Start Date
April 1 2014
End Date
November 1 2015
Last Update
June 16 2020
Active Locations (5)
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1
Hutchison Medi Pharma Investigational Site
Beijing, Beijing Municipality, China, 100071
2
Hutchison Medi Pharma Investigational Site
Guangzhou, Guangdong, China, 510060
3
Hutchison Medi Pharma
Harbin, Heilongjiang, China, 150081
4
Hutchison Medi Pharma Investigational Site
Hangzhou, Zhejiang, China, 310016