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Sponsored by: |
Fudan University |
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Information provided by: | Fudan University |
ClinicalTrials.gov Identifier: | NCT00633490 |
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 |
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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 |
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 |
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A: Experimental |
Drug: apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jin Li, PhD | jianggl@21cn.com |
China | |
Fudan University Cancer Hospital | Recruiting |
Shanghai, China, 200032 |
Principal Investigator: | Jin Li, PhD | Fudan University Cancer Hospital |
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 |
Toxicity Efficacy |