Phase I Study of Fruquintinib(HMPL-013) in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-013 at single doses and multiple doses .

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

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Collaborator: Fudan University

Criteria

Inclusion Criteria:

• ≥ 18 and ≤ 70 years of age

• Histological or cytological confirmed solid malignant tumor

• ECOG performance status of 0-1

• Standard regimen failed or no standard regimen available

• Life expectancy of more than 12 weeks

• LVEF ≥ 50%

• Duration from the last therapy is more than 4 weeks for operation or radiotherapy; more than 4 weeks for prior systemic treatment

• Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 109/L, neutrophil > 1.5 × 109/L, hemoglobin > 90g/dl ,serum creatinine within upper limit of normal(ULN), total bilirubin and serum transaminase within upper limit of normal(ULN), and PT, APTT, TT, Fbg normal

• 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 uncontrolled 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 VEGF/VEGFR inhibition

• Disability of serious uncontrolled intercurrence infection

• Proteinuria ≥ 2+

• 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