Clinical trial · Interventional
Study of Apatinib as an Inhibitor of Tumor Angiogenesis
Phase 1 Study of Apatinib as an Inhibitor of Angiogenesis
NCT00633490CI-TRIAL-00001580unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: apatinib
Primary outcomes (1)
- measure
- toxicity and tolerable dosage on the basis of NCI-CTCAE 3.0
- timeFrame
- 4 weeks
Secondary outcomes (1)
- measure
- efficacy
- timeFrame
- every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLi 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