Status:
COMPLETED
Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Lead Sponsor:
Fudan University
Conditions:
Gastric Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase...
Detailed Description
Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatis...
Eligibility Criteria
Inclusion
- ≥ 18 and ≤ 70 years of age
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- Have failed for 2 lines of chemotherapy
- Life expectancy of more than 3 months
- ECOG performance scale ≤ 2
- At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
- 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
- Adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 × 109/L, neutrophil \> 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN).
Exclusion
- Pregnant or lactating women
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00970138
Start Date
June 1 2009
End Date
December 1 2010
Last Update
July 12 2011
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032