Trials / Completed
CompletedNCT01512745
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 267 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | apatinib | apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
| DRUG | placebo | placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2012-01-19
- Last updated
- 2016-10-17
- Results posted
- 2016-06-15
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01512745. Inclusion in this directory is not an endorsement.