drugset / Trial / NCT01611857
Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach
NaSingle-groupOpen-labelTreatment
Summary
This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.
Timeline
- Start
- 2012-07
- Primary completion
- 2015-07
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tivantinib | Small molecule | 120 mg | Oral |
| Subject | Tivantinib | Small molecule | 240 mg | Oral |
| Subject | Tivantinib | Small molecule | 360 mg | Oral |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Levoleucovorin | Unknown | — | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |