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
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00633490
First received: February 24, 2008
Last updated: July 21, 2008
Last verified: March 2008
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: A |
Drug: apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily
Other Name: mesylate apatinib
|
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, Shanghai | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Jin Li, PhD | Fudan University |
More Information
No publications provided by Fudan University
Additional 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 |
| Study First Received: | February 24, 2008 |
| Last Updated: | July 21, 2008 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Toxicity Efficacy |
ClinicalTrials.gov processed this record on May 16, 2013