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

NCT ID: NCT02133157

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-10-31

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

Conditions

Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sulfatinib capsule

cohort 1: Sulfatinib single oral dosing;after 7days,Sulfatinib continuous oral dosing ( once a day) 28days as a cycle.

Group Type: EXPERIMENTAL

Sulfatinib

Intervention Type: DRUG

Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day

Interventions

Sulfatinib

Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day

Intervention Type: DRUG

Other Intervention Names

HMPL-012

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hutchison Medipharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming J Xu, PHD

Role: PRINCIPAL_INVESTIGATOR

Academy of Military Medical Affiliated Hopital

Locations

Academy of Military Medical Affiliated Hopital

Beijing, , China

Countries

China

Other Identifiers

2009-012-00CH1

Identifier Type: -

Identifier Source: org_study_id