Phase 2
Completed N=46
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
Invasive Aspergillosis
Source: ClinicalTrials.gov NCT00404092 ↗
Enrolled (actual)
46
Serious AEs
54.4%
Results posted
Jan 2013
Primary outcomePrimary: Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis — 11; 12; 9; 73 events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Caspofungin in Four Escalating Dosages in Adult Patients With Hematologic Malignancies and Proven or Probable Invasive Aspergillosis |
11; 12; 9; 73; 0; 0 | — |
| SECONDARY Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis. |
4; 3; 6; 12; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00404092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.