drugset / Trial / NCT02848443
Study of S 95005 in Combination With Oxaliplatin in Metastatic Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of this study is to assess the safety and tolerability and to determine the recommended phase 2 dose of S 95005 given in combination with oxaliplatin in patients with metastatic colorectal cancer.
Timeline
- Start
- 2016-05
- Primary completion
- 2019-08-01
- Completion
- 2020-04-09
Publications
- Background Bordonaro R, Calvo A, Auriemma A, Hollebecque A, Rubovszky G, Saunders MP, Papai Z, Prager G, Stein A, Andre T, Argiles G, Cubillo A, Dahan L, Edeline J, Leger C, Cattan V, Fougeray R, Amellal N, Tabernero J. Trifluridine/tipiracil in combination with oxaliplatin and either bevacizumab or nivolumab in metastatic colorectal cancer: a dose-expansion, phase I study. ESMO Open. 2021 Oct;6(5):100270. doi: 10.1016/j.esmoop.2021.100270. Epub 2021 Sep 20.
- Argiles G, Andre T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 65 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | trifluridine/tipiracil | Unknown | 25 mg/m2 | Oral |
| Subject | trifluridine/tipiracil | Unknown | 30 mg/m2 | Oral |
| Subject | trifluridine/tipiracil | Unknown | 35 mg/m2 | Oral |