NCT02426034

A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,004 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ApatinibTablets	Apatinib Tablets, recommended dose of 850mg

Timeline

• Start date: 2015-05-15
• Primary completion: 2020-05-29
• Completion: 2020-09-03
• First posted: 2015-04-24
• Last updated: 2022-07-01

Locations

2 sites across 1 country: China