At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years
- ✓Histologically confirmed advanced or metastatic gastric adenocarcinoma
- ✓Failed at least 2 prior lines of chemotherapy
- ✓Life expectancy at least 12 weeks
- ✕Pregnant or lactating women
- ✕Prior VEGFR inhibitor treatment
- ✕Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- ✕CNS metastasis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
In Brief
A Phase 3 clinical trial evaluating apatinib and placebo for Advanced or Metastatic Gastric Cancer. Completed, enrolled 267 participants across 2 sites.
Detailed 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 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.
Study Details
Timeline
Interventions
apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent