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Study of Apatinib as an Inhibitor of Tumor Angiogenesis
This study is currently recruiting participants.
Verified by Fudan University, March 2008
First Received: February 24, 2008   Last Updated: July 21, 2008   History of Changes
Sponsored by: Fudan University
Information provided by: Fudan University
ClinicalTrials.gov Identifier: NCT00633490
  Purpose

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 Intervention Phase
Tumor
Drug: apatinib
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • efficacy [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: July 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633490

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

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

No publications provided

Responsible Party: Fudan University cancer hospital ( Jin Li/Dr )
Study ID Numbers: 2007APA, NO
Study First Received: February 24, 2008
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00633490     History of Changes
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Toxicity
Efficacy

ClinicalTrials.gov processed this record on September 10, 2009