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.

Condition	Treatment or Intervention	Phase
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Neutropenia	Drug: Posaconazole oral suspension	Phase III

Further Study Details: 

Expected Total Enrollment:  600

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia. The primary objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in preventing proven or probable IFI during neutropenic episodes.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

California
      UCLA, Los Angeles,  California,  90095,  United States
      UCSF, Adult Lukemia and Marrow Service, San Francisco,  California,  United States
      Scripps Clinic, LaJolla,  California,  92037,  United States
      University of California San Diego, LaJolla,  California,  92037,  United States
Colorado
      Blood and Marrow Transplant Program, RMCC, Denver,  Colorado,  United States
Delaware
      Christiana Care Health Services, Newark,  Delaware,  19718,  United States
Florida
      H. Lee Moffitt Cancer Center BMT Services, Tampa,  Florida,  71130,  United States
      University of Florida Shands Cancer Center, Gainsville,  Florida,  32610-0277,  United States
      H. Lee Moffitt Cancer Center, BMT services, Tampa,  Florida,  33612,  United States
Georgia
      Emory University/Winship Cancer Institute, Atlanta,  Georgia,  30322,  United States
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Loyola University, Maywood,  Illinois,  60153,  United States
Kansas
      Kansas University Medical Center, Kansas City,  Kansas,  66160,  United States
Kentucky
      University of Kentucky Markey Cancer Center, Lexington,  Kentucky,  40536,  United States
Louisiana
      Louisiana State Univ. Medical Center, Shreveport,  Louisiana,  71130,  United States
      Louisiana State University, Medical Center, Shreveport,  Louisiana,  United States
Massachusetts
      Tufts New England Medical Center, Boston,  Massachusetts,  02111,  United States
Michigan
      Harper Hospital, Div. of ID, Detroit,  Michigan,  48201,  United States
      University of Michigan Cancer Center, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      University of Minnesota Medical Center, Minneapolis,  Minnesota,  55455,  United States
New Jersey
      Hackensack University medical Center, Hackensack,  New Jersey,  07601,  United States
      Hackensack University Medical Center, Hackensack,  New Jersey,  United States
      Hackensack University Medical Center, Hackensack,  New Jersey,  United States
New York
      Memorial Sloan Kettering Cancer Center, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States
      Cornell University Medical College, New York,  New York,  10021,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States
      Friends Hall Physician's Office Building, Philadelphia,  Pennsylvania,  United States
Texas
      Baylor University, Dallas,  Texas,  75246,  United States
      Baylor UMC, Dallas,  Texas,  75246,  United States
      Univ. of Texas, MDAAC Dept. of Oncology, Houston,  Texas,  77030,  United States
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  United States
West Virginia
      West Virginia University, Morgantown,  West Virginia,  26506,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  United States
Argentina
      Sanatorio Parque, Rosario,  Argentina
      Hospital Privado De Cordoba, Cordoba,  Argentina
      Instituto De Transplante De Medula OSEA, La Plata,  Argentina
      Fundaleu, Instituto de Transplante de Medula, Buenos Aires,  Argentina
      Sanatorio Mitre, Buenos Aires,  C1039AAN,  Argentina
Australia
      Schering Plough, Sydney,  3141,  Australia
Australia, New South Wales
      Schering Plough, Baulkham Hills,  New South Wales,  2153,  Australia
      Schering Plough, Baulkham Hills,  New South Wales,  2153,  Australia
      Schering Plough, Baulkham Hills,  New South Wales,  2153,  Australia
      Schering Plough, Baulkham Hills,  New South Wales,  2153,  Australia
Austria
      University Clinic of Innsbruck, Innsbruck,  Austria
      University Clinic of Vienna, Vienna,  Austria
Belgium
      UZ Gasthuisberg, Leuven,  3000,  Belgium
      University Hospital Antwerp (UZA), Wilrijkstaat,  B-2650,  Belgium
Brazil
      Hospital Amaral Carvalho, Jau,  Brazil
      Hospital De Clinicals Da Ufpr, Curitiba,  80060-900,  Brazil
      Hospital Amaral Carvalho, Jau,  Brazil
      Hospital Universitario Clementino Fraga Filho, Rio de Janeiro,  Brazil
      Hospital Das Clinicas Da Universidade de Marilia, Marilia,  17519-050,  Brazil
      UNICAMP, Campina,  Brazil
Canada
      Health Sciences Centre, Winnipeg,  R2A1R9,  Canada
      Hamilton Health Sciences Corporation - McMaster University, Hamilton,  Canada
      Hopital du Sacre-Coeur, Montreal,  H4J1C5,  Canada
      Hopital Maisonneuve-Rosemont, Montreal,  Canada
      Princess Margaret Hospital, Toronto,  Canada
Chile
      Hospital Luis Calvo Mackenna, Santiago,  Chile
Colombia
      Instituto De Cancerologia Clinica Las Americas, Medellin,  Colombia
      Instituto de Oncologia Carlos Ardilalulle, Bogota,  Colombia
Czech Republic
      University Hospital Olomouc, Olomouc,  77520,  Czech Republic
Denmark
      Hematological Department 4241, Copenhagen,  Denmark
Dominican Republic
      Hospital Central De Las Fuerzas Armadas Y Policia N, Santo Domingo,  Dominican Republic
Ecuador
      Hospital IESS, Quito,  Ecuador
      Hospital SOLCA, Guayaquil,  Ecuador
      Cruz Roja Ecuatoriana, Quito,  Ecuador
France
      C.H.R.U. de Lille, Hoptial Claude Huriez, Lille,  59037,  France
      Hopital Edouard Herriot, Lyon,  69437,  France
Germany
      Robert-Bosch-Krankenhaus, Stuttgart,  70376,  Germany
      Universitaet Koeln/Medizin. Klink I fuer Innere Medizin, Koeln,  Germany
      Klinikum der Johannes Gutenberg, Mainz,  Germany
      Robert-Bosch-Krankenhaus, Stuttgart,  70376,  Germany
Greece
      Peripheral University General Hospital, Patras,  Greece
      Peripheral General Hospital of Athens "G. Gennimates", Athens,  Greece
Guatemala
      Instituto Guatemalteco De Seguridad Social Hospital, ----,  01009,  Guatemala
Hungary
      St. Laszlo Hospital, Budapest,  Hungary
Italy
      Ospedale La Maddalena, Palermo,  Italy
      Azienda Ospedaliera Pisana-Ospedale Santa Chiara, Pisa,  Italy
      P.O. Binaghi A.S.L. N., Cagliari,  Italy
      Osp Ferraroto, Catania,  Italy
      Policlinico Gemelli, Roma,  Italy
      Ospedale Niguarda-Ca Grande, Milano, Milano,  Italy
Mexico
      Centro Medico Nacional Siglo XXI I.M.S.S, Mexico City,  Mexico
      Centro Medico Nacional20 de Noviembreissste, ------,  Mexico
      Hospital Universitario Dr. J.E. Gonzalez, Monterrey,  64000,  Mexico
      Hospital de Especialidades, Mexico City,  02090,  Mexico
      Hospital Central Militar, Mexico City,  11200,  Mexico
Mexico, Mexico, D.F.
      Instituto Nacional de Ciencias Medicas y Nutricion, Tlalpan 14000, D.F.,  Mexico, D.F.,  14000,  Mexico
Netherlands
      Universitair Medisch Centrum Utrecht, Utrecht,  Netherlands
      Academisch Ziekenhuis, Groningen,  9713Z,  Netherlands
Panama
      Instituto Oncologico Nacional de Panama, Panama,  Panama
Peru
      Instituto Nacional De Enfermedades, Surquillo,  Peru
      Hospital Nacional Guillermo Almenara Irigoyen, Lima,  Peru
Poland
      Department of Hematology and BMT, Katowice,  Poland
Portugal
      Instituto Portugues de Oncologia-Lisboa, Lisboa,  Portugal
Puerto Rico
      University District Hospital, San Juan,  Puerto Rico
      Hospital Municipal de San Juan, San Juan,  009367314,  Puerto Rico
Singapore
      Singapore General Hospital, Singapore,  169608,  Singapore
South Africa
      Pretoria Academic Hospital - Oncology, Pretoria,  South Africa
Spain
      Hospital Universitario "Ramon Y Cajal", Madrid,  Spain
      Hospital Universitario de Salamanca, Salamanca,  Spain
      Hospital Universitario 12 de Octubre, Madrid,  Spain
      Hospital Clinic Provincial, Barcelona,  Spain
Sweden
      Huddinge Universitetssjukhus, Stockholm,  SE14186,  Sweden
      Akademiska Hospital, Uppsala,  Sweden
      Sahlgrenska University Hospital, Goteborg,  Sweden
United Kingdom
      Guy's Hospital, London,  United Kingdom
      Glasgow Royal Infirmary, Glasgow,  United Kingdom
      University Hospital of Wales, Cardiff,  United Kingdom

Study ID Numbers:  P01899
Record last reviewed:  March 2005
Last Updated:  March 30, 2005
Record first received:  August 29, 2002
ClinicalTrials.gov Identifier:  NCT00044486
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08