drugset / Trial / NCT01309490
Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with solid tumour cancers, that have high levels of the protein eIF4E.
Timeline
- Start
- 2011-03-17
- Primary completion
- 2014-10-29
- Completion
- 2014-10-29
Publications
- Background Assouline S, Culjkovic B, Cocolakis E, Rousseau C, Beslu N, Amri A, Caplan S, Leber B, Roy DC, Miller WH Jr, Borden KL. Molecular targeting of the oncogene eIF4E in acute myeloid leukemia (AML): a proof-of-principle clinical trial with ribavirin. Blood. 2009 Jul 9;114(2):257-60. doi: 10.1182/blood-2009-02-205153. Epub 2009 May 11.
- Background Kentsis A, Topisirovic I, Culjkovic B, Shao L, Borden KL. Ribavirin suppresses eIF4E-mediated oncogenic transformation by physical mimicry of the 7-methyl guanosine mRNA cap. Proc Natl Acad Sci U S A. 2004 Dec 28;101(52):18105-10. doi: 10.1073/pnas.0406927102. Epub 2004 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 1400 mg | Oral |
| Subject | Ribavirin | Small molecule | 1800 mg | Oral |
| Subject | Ribavirin | Small molecule | 2200 mg | Oral |
| Subject | Ribavirin | Small molecule | 2600 mg | Oral |
| Subject | Ribavirin | Small molecule | 3000 mg | Oral |