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

• Status: Completed
• Trial end date: 2017-01-17
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Collaborators: Eighty-One Hospital of People's Liberation Army; Fudan University

Criteria

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