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Study of Apatinib as an Inhibitor of Tumor Angiogenesis

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Tumor Drug: apatinib Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis
Study Start Date : July 2007
Estimated Primary Completion Date : June 2008
Estimated Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: A Drug: apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
Other Name: mesylate apatinib




Primary Outcome Measures :
  1. toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. efficacy [ Time Frame: every 8 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633490


Contacts
Contact: Jin Li, PhD jianggl@21cn.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, PhD Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin Li/Dr, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00633490     History of Changes
Other Study ID Numbers: 2007APA
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: July 22, 2008
Last Verified: March 2008

Keywords provided by Fudan University:
Toxicity
Efficacy