Study of Apatinib as an Inhibitor of Tumor Angiogenesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis

Conditions
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Tumor

Intervention / Treatment
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* Drug: apatinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: apatinib<br>* apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily<br>* Other names: mesylate apatinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0 |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | every 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toxicity, Efficacy