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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis
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.
End of caspofungin treatment
Oliver A. Cornely, MD
Klinikum der Universität zu Köln
Germany: Federal Institute for Drugs and Medical Devices