Overview

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