Clinical trial NCT02133157: Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Official title: Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumor
Keywords: tumor
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 .

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating
timeFrame: 1-28days after every drug administration
Secondary outcomes:
measure: To measure the plasma concentration of HMPL-012 in single and repeated doses
timeFrame: Day 1-3 Single Dose and Day 1-56 Steady State
Other outcomes:
measure: Objective Response Rate
timeFrame: every 4 weeks until 1 year
Locations:
city: Beijing
country: China
facility: Academy of Military Medical Affiliated Hopital
Study officials:
affiliation: Academy of Military Medical Affiliated Hopital
name: Ming J Xu, PHD
role: PRINCIPAL_INVESTIGATOR
References: