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

Sponsor:

Information provided by:

Fudan University

ClinicalTrials.gov Identifier:

NCT00633490

First received: February 24, 2008

Last updated: July 21, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2008

Last Updated Date

July 21, 2008

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00633490 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

efficacy [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Apatinib as an Inhibitor of Tumor Angiogenesis

Official Title ^ICMJE

Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Tumor

Intervention ^ICMJE

Drug: apatinib

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

Other Name: mesylate apatinib

Study Arm (s)

Experimental: A

Intervention: Drug: apatinib

Publications *

Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 Oct 5;10:529.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2008

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jin Li, PhD

jianggl@21cn.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00633490

Other Study ID Numbers ^ICMJE

2007APA

Has Data Monitoring Committee

Responsible Party

Jin Li/Dr, Fudan University cancer hospital

Study Sponsor ^ICMJE

Fudan University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jin Li, PhD

Fudan University

Information Provided By

Fudan University

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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