Study of Apatinib as an Inhibitor of Tumor Angiogenesis

Fudan University

Status and phase

Unknown

Phase 1

Conditions

Tumor

Treatments

Drug: apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT00633490

2007APA

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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