drugset / Trial / NCT01481532
Open Label Clinical Trial of Intravenous Crotoxin Part 3
Phase 1
Not yet recruiting
24 enrolled
Celtic Biotech Ltd
Institut de Cancérologie de l'Ouest · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.
Timeline
- Start
- 2026-10
- Primary completion
- 2027-10
- Completion
- 2027-11
Publications
- Background Delgado MG, Gougis P, Bray DH, Delgado FM, Spano JP, Idbaih A, Reid PF, Benlhassan K, Diaw C, Khayat D. Abstract CT071: Continuous i.v. Crotoxin in advanced cancer: Intra-patient dose escalation. Cancer Res (2018) 78 (13_Supplement): CT071. https://doi.org/10.1158/1538-7445.AM2018-CT071
- Background Medioni J, Brizard M, Elaidi R, Reid PF, Benlhassan K, Bray D. Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study. Contemp Clin Trials Commun. 2017 Jul 23;7:186-188. doi: 10.1016/j.conctc.2017.07.008. eCollection 2017 Sep.
- Background Gil-Delgado M, Paul G, Bray DH, Delgado F, Spano JP, Idbaih A, Reid PF, Benlhassan K, Diaw C, Khayat D. Continuous i.v. Crotoxin in advanced cancer: Intra-patient dose escalation. Cancer Res (2018) 78 (13_Supplement): CT071.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crotoxin | Unknown | — | Intravenous |