A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.

The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

Sponsors

Lead sponsor: Pfizer

Collaborator: Vicuron Pharmaceuticals

Source Pfizer
Brief Summary

Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.

Overall Status Completed
Start Date August 2002
Completion Date August 2004
Phase Phase 2
Study Type Interventional
Enrollment 19
Condition
Intervention

Intervention type: Drug

Intervention name: Anidulafungin, VER002

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole)

- Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast

Exclusion Criteria:

- Pregnant female

- Hypersensitivity to anidulafungin or echinocandin therapy

- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

- Abnormal blood chemistries: Bilirubin >2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 4 times the upper limit of normal

- Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents

- Patients taking other systemic antifungal therapies while on this study

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility Versicor, Inc.
Location Countries

United States

Verification Date

October 2008

Responsible Party

Name title: Director, Clinical Trial Disclosure Group

Organization: Pfizer, Inc.

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov