Study of Apatinib as an Inhibitor of Tumor Angiogenesis

Tumor Clinical Trial

Official title:

Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00633490
• Other study ID #: 2007APA
• Status: Recruiting
• Phase: Phase 1
• First received: February 24, 2008
• Last updated: July 21, 2008
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: March 2008
• Source: Fudan University
• Contact: Jin Li, PhD
• Email: jianggl[@]21cn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• apatinib
apatinib is a tablet in the form of 250mg and 100mg and 50mg, orally, daily

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0		4 weeks	Yes
Secondary	efficacy		every 8 weeks	Yes