A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Study ID
- NCT02426034
- Phase
- PHASE4
- Status
- Completed
Conditions
- Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- ApatinibTablets — DRUGApatinib Tablets, recommended dose of 850mg
Study Details
The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
Key Dates
- Start date
- May 15, 2015
- Status verified
- Jun 2022
- Primary completion
- May 29, 2020
- Completion
- Sep 3, 2020
Study Design
- Enrollment
- 2,004 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment groupApatinib Tablets
Primary Outcome Measure
Safety, which was assessed by recording the incidence and severity of adverse events [ Time Frame: between first dose of apatinib and up to 30 days after the last dose of apatinib ]