drugset / Trial / NCT02401971
Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer
Phase 4
Unknown
900 enrolled
Wang Jufeng
Henan Provincial People's Hospital · collabSecond Affiliated Hospital of Zhengzhou University · collabThe First Affiliated Hospital of Henan University of Science and Technology · collabThe First Affiliated Hospital of Zhengzhou University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.
Timeline
- Start
- 2014-08
- Primary completion
- 2016-08
- Completion
- 2018-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Thalidomide | Other / unclassified | 100 mg | Oral |