Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis
A Phase II Dose Escalation Study of Caspofungin in Patients With Invasive Aspergillosis
2 other identifiers
interventional
46
2 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2006
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 24, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
January 21, 2013
CompletedJuly 31, 2013
July 1, 2013
3 years
November 24, 2006
December 12, 2012
July 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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, treatment duration varied between 3 and 29 days (mean: 20.5; median: 24.5)
Secondary Outcomes (1)
Efficacy of Caspofungin in Four Escalating Dosages in the Treatment of Proven or Probable Invasive Aspergillosis.
End of caspofungin treatment; 4 weeks follow-up; 12 weeks follow-up
Study Arms (4)
1st cohort
EXPERIMENTAL70mg caspofungin 1x/day
2nd cohort
EXPERIMENTAL100mg caspofungin 1x/day
3rd cohort
EXPERIMENTAL150mg caspofungin 1x/day
4th cohort
EXPERIMENTAL200mg caspofungin 1x/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University Hospital Gasthuisberg
Leuven, 3000, Belgium
Charité - Campus Benjamin Franklin
Berlin, 12200, Germany
Klinikum der Universität zu Köln
Cologne, 50924, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Related Publications (2)
Cornely OA, Vehreschild JJ, Vehreschild MJ, Wurthwein G, Arenz D, Schwartz S, Heussel CP, Silling G, Mahne M, Franklin J, Harnischmacher U, Wilkens A, Farowski F, Karthaus M, Lehrnbecher T, Ullmann AJ, Hallek M, Groll AH. Phase II dose escalation study of caspofungin for invasive Aspergillosis. Antimicrob Agents Chemother. 2011 Dec;55(12):5798-803. doi: 10.1128/AAC.05134-11. Epub 2011 Sep 12.
PMID: 21911573RESULTWurthwein G, Cornely OA, Trame MN, Vehreschild JJ, Vehreschild MJ, Farowski F, Muller C, Boos J, Hempel G, Hallek M, Groll AH. Population pharmacokinetics of escalating doses of caspofungin in a phase II study of patients with invasive aspergillosis. Antimicrob Agents Chemother. 2013 Apr;57(4):1664-71. doi: 10.1128/AAC.01912-12. Epub 2013 Jan 18.
PMID: 23335740RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Oliver A. Cornely
- Organization
- University of Cologne
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver A. Cornely, MD
Klinikum der Universität zu Köln
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Oliver Cornely
Study Record Dates
First Submitted
November 24, 2006
First Posted
November 27, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
July 31, 2013
Results First Posted
January 21, 2013
Record last verified: 2013-07