Tumor
Conditions
Keywords
Toxicity, Efficacy
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.
Interventions
DRUGapatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0 | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| efficacy | every 8 weeks |
Countries
China
Contacts
Primary ContactJin Li, PhD
Outcome results
None listed