Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Study ID
- NCT01512745
- Phase
- PHASE3
- Status
- Completed
Conditions
- Advanced or Metastatic Gastric Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- apatinib — DRUGapatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
- placebo — DRUGplacebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Study Details
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 I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.
Key Dates
- Start date
- Jan 31, 2011
- Status verified
- Apr 2015
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
Study Design
- Enrollment
- 267 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: apatinib
- Placebo Comparator: placebo
Primary Outcome Measure
Progression Free Survival(PFS) [ Time Frame: 30 months ]