drugset / Trial / NCT00877474
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase I, multicenter, open-label, dose escalating clinical and pharmacokinetic study of PM01183 for patients with advanced solid tumors
Timeline
- Start
- 2009-03
- Primary completion
- 2011-06
- Completion
- 2011-06
Publications
- Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9.
- Elez ME, Tabernero J, Geary D, Macarulla T, Kang SP, Kahatt C, Pita AS, Teruel CF, Siguero M, Cullell-Young M, Szyldergemajn S, Ratain MJ. First-in-human phase I study of Lurbinectedin (PM01183) in patients with advanced solid tumors. Clin Cancer Res. 2014 Apr 15;20(8):2205-14. doi: 10.1158/1078-0432.CCR-13-1880. Epub 2014 Feb 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lurbinectedin | Other / unclassified | 0.02 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 4 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 5 mg/m2 | Intravenous |
| Subject | Lurbinectedin | Other / unclassified | 7 mg | Intravenous |