Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors

HUTCHMED

Status and phase

Completed

Phase 1

Conditions

Tumor

Treatments

Drug: Sulfatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02133157

2009-012-00CH1

Details and patient eligibility

About

Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity 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 recommended dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-012 at single doses and multiple doses .

Full description

This will be an open-label, phase I study. This study will evaluate the safety and pharmacokinetics of HMPL-012 after a single administration followed by a 28-Day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the MTD. All subjects of this study will be permitted to continue therapy with only safety monitoring and monthly assessments for progression, if the product is well tolerated and the subject has stable disease or better

Enrollment

71 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

•≥ 18 and ≤ 70 years of age

Histological or cytological confirmed solid malignant tumor
ECOG performance status of 0-2
Standard regimen failed or no standard regimen available
Life expectancy of more than 12 weeks
LVEF ≥ 50%

Exclusion criteria

Pregnant or lactating women
Adequate hepatic, renal, heart, and hematologic functions (platelets <75 × 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
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
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