Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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

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Invasive Aspergillosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1st cohort

70mg caspofungin 1x/day

Group Type EXPERIMENTAL

caspofungin

Intervention Type DRUG

i.v.

2nd cohort

100mg caspofungin 1x/day

Group Type EXPERIMENTAL

caspofungin

Intervention Type DRUG

i.v.

3rd cohort

150mg caspofungin 1x/day

Group Type EXPERIMENTAL

caspofungin

Intervention Type DRUG

i.v.

4th cohort

200mg caspofungin 1x/day

Group Type EXPERIMENTAL

caspofungin

Intervention Type DRUG

i.v.

Interventions

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caspofungin

i.v.

Intervention Type DRUG

Other Intervention Names

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cancidas

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No