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Study of Apatinib as an Inhibitor of Tumor Angiogenesis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00633490
First received: February 24, 2008
Last updated: July 21, 2008
Last verified: March 2008

February 24, 2008
July 21, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00633490 on ClinicalTrials.gov Archive Site
efficacy [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumor
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
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
Both
18 Years to 70 Years
No
Contact: Jin Li, PhD jianggl@21cn.com
China
 
NCT00633490
2007APA
No
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