drugset / Trial / NCT03244774
Phase I Study of the Combination of Apatinib and POF
NaSingle-groupOpen-labelTreatment
Summary
In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators initialize this dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) of apatinib in this study.
Timeline
- Start
- 2018-01-01
- Primary completion
- 2018-12-31
- Completion
- 2019-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivoceranib | Small molecule | 250 mg | Oral |
| Subject | Rivoceranib | Small molecule | 375 mg | Oral |
| Subject | Rivoceranib | Small molecule | 500 mg | Oral |
| Subject | Rivoceranib | Small molecule | 625 mg | Oral |
| Subject | Rivoceranib | Small molecule | 750 mg | Oral |
| Background | Levoleucovorin | Unknown | 200 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 135 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |