None listed
Conditions
Interventions
usual treatment Type of group
The subjects will receive a usual administration of azole treatment (400 mg of fluconazole suspension once a day or 200 mg of itraconazole oral solution twice a day) with each cycle of neutropenia, for a maximum of 12 weeks.
Group name:posaconazole Type of group
Subjects will receive 200 mg of posaconazole suspension three times a day for up to 12 weeks.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: *Adults or adolescents (age>13 years) and weight> 34kg, either gender *Disease definition: Anticipated or documented prolonged neutropenia (ANC<500/mm3 2) Eastern Cooperative Oncology Group (ECOG) performance score of less than 3. *Female subjects of childbearing age must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). *Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hcG) at Baseline or within 72 hours before the start of the study drug.
Exclusion criteria
Exclusion criteria: *Female subjects who are pregnant, intend to become pregnant, or are nursing. *Excluded prior treatments: Subjects previously treated with AMB, FLZ, or ITZ for proven or probable IFI within 30 days of enrollment. *Excluded treatments prior to specific study phases: Subjects who have taken the following drugs: those known to interact with azoles and that may lead to life-threatening side effects. *Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry. *Subjects who are participating in any other blinded clinical study within 30 days of study entry. *Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at Baseline or likely to require dialysis during the study). *Subjects having an ECG with a prolonged QTc interval by manual reading: QTc greater than 450 msec for men and greater than 470 msec for women. *Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Efficacy is measured by the incidence of proven or probable invasive fungal infections (according to the rating assigned to them by a panel of external examiners) during the period from the day of randomization to the end of treatment with the oral study drug, plus 7 days. Measure:Efficacy of posaconazole in the prevention of proven and probable invasive fungal infections, in comparison with the reference arm of azoles treatments. Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) General mortality during the episodes of neutropenia, compared with the usual administration of azoles and historical controls. 2) Overall mortality during the study period (up to 100 days of follow-up after randomization). 3) Mortality related to mycoses during the Treatment Phase. 4) Analysis of the clinical adverse events that occurred with the administration of posaconazole in comparison with the analysis of the adverse events that occurred with the azole treatments of usual administration. 5) Analysis of the abnormal results of the laboratory tests that were obtained with the administration of posaconazole in comparison with the abnormal results of the laboratory tests that were obtained with the azole treatments of usual administration. 6) Interruptions due to the appearance of adverse events or safety laboratory tests. Measure:Safety and tolerance of posaconazole in the prophylaxis of invasive mycoses in this population. Timepoints:week 12 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Panama, Peru, Poland, Portugal, Singapore, South Africa, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed