A Phase Ib Study of Fruquintinib in 3rd Line mCRC

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these 2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and regimen in phase II/III study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• ≥ 18 and ≤ 70 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)

• Uncontrolled hemorrhage in GI

• 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