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An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections


Phase 3
N/A
N/A
Not Enrolling
Both
Mycoses

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Trial Information

An Open Label, Non-Comparative, Multi-Center Phase III Trial of the Efficacy, Safety, and Toleration of Extended Voriconazole in the Treatment of Invasive Fungal Infections


The objective of this study is to evaluate the efficacy, safety and toleration of
voriconazole in the treatment of systemic or invasive fungal infections due to fungal
pathogens for which there is no licensed therapy or that are unresponsive or intolerant to
treatment with approved systemic antifungal agents. This trial is an extension of the Phase
III multicenter, open label study investigating the utilization of voriconazole for the
treatment of systemic or invasive fungal infections. Enrollment is targeted for 100
patients to be recruited from multiple centers. The patient population will consist of
patients with proven deeply invasive fungal infection for which there is no licensed therapy
or if the patient is failing or intolerant to treatment with approved systemic antifungal
agents and currently on the voriconazole (99-C-0094) protocol. Voriconazole will be
administered intravenously at 3-4 mg/kg q 12 hours or orally at 200-300 mg BID. Efficacy
will be evaluated by clinical, radiological and microbiological response.

Inclusion Criteria


Males or (non-pregnant, lactating and nursing) females equal to or greater than 12 years
of age.

Previous enrollment into and completion of voriconazole therapy in protocol 99-C-0094
investigating the use of voriconazole in the treatment of invasive fungal disease or
empirical treatment of presumed fungal infections and enrolled within three weeks of
completion of 99-C-0094B.

Clinical benefit was derived from previous voriconazole treatment.

Further clinical benefit is expected with extended voriconazole treatment.

Women of child bearing potential (or less than 2 years post- menopausal) must have a
negative serum pregnancy test at baseline, and must agree to use barrier methods of
contraception during the study.

Signed written informed consent must be obtained at protocol entry.

Assent will be obtained from minors capable of understanding.

Subjects must not have either ongoing serious adverse events probably related to
voriconazole therapy or have ongoing adverse events probably related to voriconazole
therapy which may pose a significant risk on continued therapy.

Must not have previously participated in this trial.

If receiving, must be able to discontinue the following drugs at least 24 hours prior to
randomization: terfenadine, cisapride, and astemizole.

If receiving, must be able to discontinue sulphonylureas at least 24 hours prior to
randomization.

Must not have received the following drugs within 14 days prior to randomization:
rifampin, carbamazepine, or barbiturates.

Must not have AST, ALT, greater than 10 (upper limit normal).

Must not have serum creatinine greater than 3.0 mg/dl.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

000024

NCT ID:

NCT00001940

Start Date:

December 1999

Completion Date:

July 2001

Related Keywords:

  • Mycoses
  • Antifungal Agent
  • Aspergillosis
  • Candidemia
  • Fungemia
  • Mycoses

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892