CClinicalTrials.gg
Status unknownNCT00633490Updated Jul 22, 2008

Study of Apatinib as an Inhibitor of Tumor Angiogenesis

A Phase 1 interventional study of apatinib in Tumor, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-07-22.

Sponsored by Fudan University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Tumor

Keywords

  • Toxicity
  • Efficacy
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In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    A

    Drug: apatinib

Interventions

  • Drugapatinib

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

    Also known as: mesylate apatinib

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What researchers measure

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. efficacy

    Time frame: every 8 weeks

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Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Hospital
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

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. doi: 10.1186/1471-2407-10-529. PubMed 20923544 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00633490
Lead sponsor
Fudan University
First posted
Mar 12, 2008
Start date
Jul 2007
Primary completion
Jun 2008 (estimated)
Completion
Jun 2008 (estimated)
Last update
Jul 22, 2008

Study contacts

Jin Li, PhD
Contact
jianggl@21cn.com
Jin Li, PhD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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