drugset / Trial / NCT00404092
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or probable invasive aspergillosis.
Timeline
- Start
- 2006-10
- Primary completion
- 2009-10
- Completion
- 2009-10
Publications
- Results Cornely OA, Vehreschild JJ, Vehreschild MJ, Wurthwein G, Arenz D, Schwartz S, Heussel CP, Silling G, Mahne M, Franklin J, Harnischmacher U, Wilkens A, Farowski F, Karthaus M, Lehrnbecher T, Ullmann AJ, Hallek M, Groll AH. Phase II dose escalation study of caspofungin for invasive Aspergillosis. Antimicrob Agents Chemother. 2011 Dec;55(12):5798-803. doi: 10.1128/AAC.05134-11. Epub 2011 Sep 12.
- Results Wurthwein G, Cornely OA, Trame MN, Vehreschild JJ, Vehreschild MJ, Farowski F, Muller C, Boos J, Hempel G, Hallek M, Groll AH. Population pharmacokinetics of escalating doses of caspofungin in a phase II study of patients with invasive aspergillosis. Antimicrob Agents Chemother. 2013 Apr;57(4):1664-71. doi: 10.1128/AAC.01912-12. Epub 2013 Jan 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caspofungin | Other / unclassified | 70 mg | Intravenous |
| Subject | Caspofungin | Other / unclassified | 100 mg | Intravenous |
| Subject | Caspofungin | Other / unclassified | 150 mg | Intravenous |
| Subject | Caspofungin | Other / unclassified | 200 mg | Intravenous |