Study of Apatinib as an Inhibitor of Tumor Angiogenesis

NCT00633490 | Unknown Phase 1

• 1 other identifier: 2007APA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor

Keywords

Toxicity; Efficacy

Outcome Measures

Primary Outcomes (1)

• toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0

  4 weeks

Secondary Outcomes (1)

• efficacy

  every 8 weeks

Study Arms (1)

A

EXPERIMENTAL

Drug: apatinib

Interventions

apatinib DRUG

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

Also known as: mesylate apatinib

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/1471-2407-10-529.

  PMID: 20923544 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

apatinib

Study Officials

• Jin Li, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li, PhD

CONTACT

jianggl@21cn.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 12, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 22, 2008

Record last verified: 2008-03

Locations

CN (1)