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

NCT02133157 | Completed Phase 1 DMC

• 1 other identifier: 2009-012-00CH1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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 .

Conditions

Tumor

Keywords

tumor

Outcome Measures

Primary Outcomes (1)

• To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating

  The primary endpoint is evaluation of safety during the first 28-day cycle 1 of therapy following the initiation of multiple dosing of HMPL-012. The safety variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology , and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate

  1-28days after every drug administration

Secondary Outcomes (1)

• To measure the plasma concentration of HMPL-012 in single and repeated doses

  Day 1-3 Single Dose and Day 1-56 Steady State

Other Outcomes (1)

• Objective Response Rate

  every 4 weeks until 1 year

Study Arms (1)

Sulfatinib capsule

EXPERIMENTAL

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

Drug: Sulfatinib

Interventions

Sulfatinib DRUG

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

Also known as: HMPL-012

Sulfatinib capsule

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Academy of Military Medical Affiliated Hopital

Beijing, 100071, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

surufatinib

Study Officials

• Ming J Xu, PHD

  Academy of Military Medical Affiliated Hopital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: May 7, 2014
• Study Start: April 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

CN (1)