Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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 patients with advanced Colorectal Cancer (CRC) in Phase Ib 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 metastatic CRC second line or above standard chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Collaborators: Fudan University; Sun Yat-sen University

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