Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)

NCT ID: NCT00811928

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-05-31

Brief Summary

A randomized, open label parallel controlled, multicenter study to evaluate safety and efficacy of Posaconazole oral suspension vs Fluconazole (capsule) in high-risk leukopenic patients for prevention of invasive fungal infection

Conditions

Leukopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Posaconazole

Posaconazole oral suspension 200 mg three times a day (TID)

Group Type: ACTIVE_COMPARATOR

Posaconazole

Intervention Type: DRUG

40 mg/mL; 200 mg (5 mL) TID

Treatment was continued with each cycle of chemotherapy until:

• The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
• 3 chemotherapy cycles or
• Total treatment duration up to 12 weeks (84 days)

Fluconazole

Fluconazole 400 mg once daily (QD)

Group Type: ACTIVE_COMPARATOR

Fluconazole

Intervention Type: DRUG

50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules);

400 mg QD

Treatment was continued with each cycle of chemotherapy until:

• The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
• 3 chemotherapy cycles or
• Total treatment duration up to 12 weeks (84 days)

Interventions

Posaconazole

40 mg/mL; 200 mg (5 mL) TID

Treatment was continued with each cycle of chemotherapy until:

• The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
• 3 chemotherapy cycles or
• Total treatment duration up to 12 weeks (84 days)

Intervention Type: DRUG

Fluconazole

50 mg/capsule (2 capsules), 150 mg/capsule (2 capsules);

400 mg QD

Treatment was continued with each cycle of chemotherapy until:

• The onset of a proven or probable diagnosis of invasive fungal infection (IFI)
• 3 chemotherapy cycles or
• Total treatment duration up to 12 weeks (84 days)

Intervention Type: DRUG

Other Intervention Names

Noxafil; SCH 056592

Eligibility Criteria

Inclusion Criteria

• Participants must be 18-70 years of age of either sex
• Persistent neutropenia (Absolute Neutrophil Count [ANC] < 500/mm^3 [0.5x10^9/L]）or probable neutropenia in 3-5 days is anticipated. Neutropenia >= 7 days caused by the following reasons

• Standard or dose-intense chemotherapy, anthracyclines or other acceptable chemotherapies ( any investigational drug is not permitted) for Acute Myelogenous Leukemia (AML) treatment
• Retreatment of chemotherapy in case of AML recurrence
• Myelodysplastic syndrome (MDS) shifts to AML and bone marrow arrest induction chemotherapy is required (not including acute phase of chronic myelogenous leukemia [CML])
• Informed consent obtained from participant or legal guardian

Exclusion Criteria

• Participants previously treated with amphotericin B (AMB), fluconazole (FLZ), or itraconazole (ITZ) within 30 days of enrollment.
• Participants who have taken the following drugs:

• terfenadine, cisapride, and ebastine within 24 hours before entry
• astemizole at entry or within 10 days before entry
• cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
• The above drugs are refrained during the investigation
• Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
• Participants who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
• Prior enrollment in this study.
• Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B.
• Participants with known or suspected invasive fungal infection (IFI) at screen
• Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), Alanine transaminase (ALT), Aspartate transaminase (AST), alkaline phosphatase or total bilirubin are >2× (Upper Limit of Normal) ULN.
• Participants having an electrocardiogram (ECG) with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
• Participants with AML or CML history.
• Participants with a history of allogeneic hematopoietic stem cell, bone marrow transplantation, autologous stem cell transplantation history.
• Female participants who are pregnant or are nursing.
• Alcohol and/or drug abuse.
• Participants cannot be compliant in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Shen Y, Huang XJ, Wang JX, Jin J, Hu JD, Yu K, Wu DP, Wang SJ, Yu L, Chen XQ, Liu T, Liang YM, Chen FP, Li Y, Shen ZX. Posaconazole vs. fluconazole as invasive fungal infection prophylaxis in China: a multicenter, randomized, open-label study. Int J Clin Pharmacol Ther. 2013 Sep;51(9):738-45. doi: 10.5414/CP201880.

Reference Type: DERIVED

PMID: 23924680 (View on PubMed)

Other Identifiers

P05387

Identifier Type: -

Identifier Source: org_study_id