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Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis

Phase 1
18 Years
70 Years
Open (Enrolling)

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Trial Information

Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Jin Li, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

July 2007

Completion Date:

June 2008

Related Keywords:

  • Tumor
  • Toxicity
  • Efficacy