Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00404092
Study type	Interventional
Source	University of Cologne
Contact
Status	Completed
Phase	Phase 2
Start date	October 2006
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06028451` - ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study
Completed	`NCT00163722` - A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients	Phase 3
Completed	`NCT02394483` - Single Ascending Oral Dose Study of F901318	Phase 1
Completed	`NCT01128907` - Galactomannan Antigen in Bronchoalveolar Lavage in the Diagnosis of Invasive Aspergillosis in Neutropenic Patients	N/A
Recruiting	`NCT01386437` - Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Withdrawn	`NCT02912026` - Radiolabelled IV and Oral Metabolism Study of F901318	Phase 1
Withdrawn	`NCT03076905` - Pharmacokinetics of IV Formulation	Phase 1
Withdrawn	`NCT03095547` - Drug/Drug Interactions With F901318	Phase 1
Completed	`NCT02737371` - Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects	Phase 1
Terminated	`NCT00836875` - A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children	Phase 3
Active, not recruiting	`NCT00838643` - Invasive Aspergillosis After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)	N/A
Terminated	`NCT04876716` - Azole-echinocandin Combination Therapy for Invasive Aspergillosis	Phase 3
Recruiting	`NCT05101187` - Olorofim Aspergillus Infection Study	Phase 3
Enrolling by invitation	`NCT02104479` - Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
Not yet recruiting	`NCT05707832` - A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus	Phase 3
Recruiting	`NCT06382922` - Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy
Terminated	`NCT02396225` - Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration	N/A
Recruiting	`NCT00843804` - Surveillance for Nosocomial Infections in Pediatric Cancer Patients	N/A
Completed	`NCT00334412` - COMBISTRAT: AmBisome® in Combination With Caspofungin for the Treatment of Invasive Aspergillosis	Phase 4
Completed	`NCT04550936` - Patterns of Real-World Isavuconazole Use - a Study of Patients With Mucormycosis or Invasive Aspergillosis