Overview

Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)

Status:
Completed
Trial end date:
2005-04-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections. Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome. Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Posaconazole
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:

- 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.