Study of Apatinib as an Inhibitor of Tumor Angiogenesis

Phase 1

• Conditions: Tumor
• Interventions: Drug: apatinib

• Registration Number: NCT00633490
• Lead Sponsor: Fudan University

Brief Summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor patients.

Detailed Description

Apatinib is a tyrosin-inhibitor agent targeting at VEGFR (vasoendothelial growth factor receptor) to inhibit tumor angiogenesis. The anti-angiogenesis effect of apatinib has been viewed in preclinical tests (see protocol). This phase I clinical study is going to evaluate its toxicity and to find an appropriate dose level to be used in a phase II study in heavily treated solid tumor patients.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-02-24
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-07-21
• Last Update Posted: 2008-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• ≥ 18 and ≤ 70 years of age
• Histological or cytological confirmed solid malignant tumor
• ECOG performance status of ≤ 2
• Standard regimen failed or no standard regimen available
• Life expectancy of more than 3 months
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin; more than 4 weeks for operation or radiotherapy; more than 4 weeks for cytotoxic agents or growth inhibitors.
• Laboratory values: hemoglobin ≥ 9.0g/dl, neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L , ALT ≤ 2.5 x upper limit of normal (ULN), AST ≤ 2.5 x ULN, serum bilirubin ≤ 1.5 x ULN, serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, PT, APTT, TT, Fbg normal

Exclusion Criteria

• Pregnant or lactating women
• Any factors that influence the usage of oral administration
• Evidence of CNS metastasis
• History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
• Receiving the therapy of thrombolysis or anticoagulation
• Abuse of alcohol or drugs
• Allergy to the ingredient of the agent or more than two kinds of food and drug
• Less than 4 weeks from the last clinical trial
• Disability of serious uncontrolled intercurrence infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	apatinib	-

Primary Outcome Measures

Name	Time	Method
toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0	4 weeks

Secondary Outcome Measures

Name	Time	Method
efficacy	every 8 weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China