Study of Apatinib as an Inhibitor of Tumor Angiogenesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633490
Recruitment Status : Unknown
Verified March 2008 by Fudan University.
Recruitment status was:  Recruiting
First Posted : March 12, 2008
Last Update Posted : July 22, 2008
Information provided by:
Fudan University

February 24, 2008
March 12, 2008
July 22, 2008
July 2007
June 2008   (Final data collection date for primary outcome measure)
toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0 [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT00633490 on Archive Site
efficacy [ Time Frame: every 8 weeks ]
Same as current
Not Provided
Not Provided
Study of Apatinib as an Inhibitor of Tumor Angiogenesis
Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis
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.
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
Other Name: mesylate apatinib
Experimental: A
Intervention: Drug: apatinib
Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 Oct 5;10:529. doi: 10.1186/1471-2407-10-529.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Jin Li/Dr, Fudan University cancer hospital
Fudan University
Not Provided
Principal Investigator: Jin Li, PhD Fudan University
Fudan University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP