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

Phase 2
18 Years
Not Enrolling
Invasive Aspergillosis

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis

Outcome Description:

Endpoints of safety and tolerability are the number of toxicity-related study therapy discontinuations and grade III and IV clinical and laboratory events, as evaluated on the basis of current NCI criteria.

Outcome Time Frame:

End of caspofungin treatment

Safety Issue:


Principal Investigator

Oliver A. Cornely, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinikum der Universität zu Köln


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2006

Completion Date:

October 2009

Related Keywords:

  • Invasive Aspergillosis
  • aspergillosis
  • caspofungin
  • maximum tolerated dose
  • Aspergillosis