NCT00404092

Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Due to its efficacy and a broad antifungal spectrum against relevant fungal pathogens, lack of cross-resistance to azoles and amphotericin B, documented efficacy against human Aspergillus infections, favorable pharmacokinetic properties, and excellent tolerability according to the current data, caspofungin is a highly promising candidate for improving the results of treatment of invasive fungal infections. Preclinical and clinical data indicate a dose dependent antifungal efficacy of caspofungin as well as of other echinocandins such as micafungin and anidulafungin. Thus it appears reasonable to investigate the impact of higher doses of caspofungin to improve the results already achieved with this component so far. The maximum tolerated dose (MTD) of caspofungin and the distribution of the drug in patients following administration of doses of 70 mg or more are not yet known. We therefore investigate the safety, tolerability and pharmacokinetics of caspofungin in rising doses in a dose escalation study in adult patients with proven or probable invasive aspergillosis.

Conditions

• Invasive Aspergillosis

Interventions

Type	Name	Description
DRUG	caspofungin	i.v.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-11-27
• Last updated: 2013-07-31
• Results posted: 2013-01-21

Locations

4 sites across 2 countries: Belgium, Germany