Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Active 18 and over Other Uni-Koeln-687 EudraCT- No.: 2006-001936-30, NCT00404092

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

• Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.

• Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria

Exclusion Criteria:

• Concomitant other systemic antifungal agents are not permitted on study.

• Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study

• Prior systemic therapy of ≥ 4 days with any polyene anti-fungal agent within 14 days of study enrollment

• Prior systemic therapy of ≥ 4 days with non-polyenes for the current, documented IFI.

Trial Contact Information

Trial Lead Organizations/Sponsors

Medizinische Universitaetsklinik I at the University of Cologne

Oliver A. Cornely, MD

Principal Investigator

Oliver A. Cornely, MD		Ph: +49-221-478 6494
		Email: oliver.cornely@uni-koeln.de

Dorothee Arenz		Ph: +49-221-478 88790
		Email: dorothee.arenz@uni-koeln.de

Germany
	Berlin
	Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
		Stefan Schwartz, MD	Principal Investigator
	Köln
	Medizinische Universitaetsklinik I at the University of Cologne
		Dorothee Arenz	Ph: +49-221-478 6494
			Email: dorothee.arenz@uni-koeln.de
		Oliver A. Cornely, MD	Principal Investigator
	Münster
	Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
		Andreas H. Groll, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00404092
Information obtained from ClinicalTrials.gov on July 16, 2008