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

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; Recruiting
      Cedar-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Terminated
      UCSF, Adult Lukemia and Marrow Service, San Francisco,  California,  United States; Terminated
      UCLA, dept. of medicien, Los Angeles,  California,  90095,  United States; Recruiting
      Scripps Clinic, LaJolla,  California,  92037,  United States; Recruiting
      University of California San Diego, LaJolla,  California,  92037,  United States; Recruiting
Colorado
      Bone Marrow Transplant Program RMCC, Denver,  Colorado,  80218,  United States; Recruiting
      Blood and Marrow Transplant Program, RMCC, Denver,  Colorado,  United States; Recruiting
Delaware
      Christiana Care Health Services, Newark,  Delaware,  19718,  United States; Completed
Florida
      H. Lee Moffitt Cancer Center BMT Services, Tampa,  Florida,  71130,  United States; Recruiting
      University of Florida Shands Cancer Center, Gainsville,  Florida,  32610-0277,  United States; Recruiting
      H. Lee Moffitt Cancer Center, BMT services, Tampa,  Florida,  33612,  United States; Recruiting
Georgia
      Emory University/Winship Cancer Institute, Atlanta,  Georgia,  30322,  United States; Recruiting
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States; Recruiting
Illinois
      Loyloa University, Maywood,  Illinois,  60153,  United States; Recruiting
Kansas
      Kansas University Medical Center, Kansas City,  Kansas,  66160,  United States; Recruiting
Kentucky
      University of Kentucky Markey Cancer Center, Lexington,  Kentucky,  40536,  United States; Recruiting
Louisiana
      Louisiana State Univ. Medical Center, Shreveport,  Louisiana,  71130,  United States; Recruiting
      Louisiana State University, Medical Center, Shreveport,  Louisiana,  United States; Recruiting
Massachusetts
      Tufts New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Michigan
      Harper Hospital, Div. of ID, Detroit,  Michigan,  48201,  United States; Recruiting
      University of Michigan Cancer Center, Ann Arbor,  Michigan,  48109,  United States; Recruiting
Minnesota
      University of Minnesota Medical Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
New Jersey
      Hackensack University medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
      Hackensack University Medical Center, Hackensack,  New Jersey,  United States; Recruiting
      Hackensack University Medical Center, Hackensack,  New Jersey,  United States; Recruiting
New York
      Memorial Sloan Kettering Cancer Center, New York,  New York,  10021,  United States; Terminated
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States; Recruiting
      Cornell University Medical College, New York,  New York,  10021,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States; Recruiting
      Oregon Health Scienced University, Portland,  Oregon,  97239,  United States; Recruiting
Pennsylvania
      University of Pennsyvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Hospital of University of Pennsylvania, Philadelphia,  Pennsylvania,  United States; Recruiting
      Friends Hall Physician's Office Building, Philadelphia,  Pennsylvania,  United States; Terminated
Texas
      Baylor University, Dallas,  Texas,  75246,  United States; Recruiting
      Baylor UMC, Dallas,  Texas,  75246,  United States; Recruiting
      Univ. of Texas, MDAAC Dept. of Oncology, Houston,  Texas,  77030,  United States; Recruiting
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  United States; Terminated
West Virginia
      West Virginia University, Morgantown,  West Virginia,  26506,  United States; Recruiting
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  United States; Terminated
Argentina
      Sanatorio Parque, Rosario,  Argentina; Recruiting
      Hospital Privado De Cordoba, Cordoba,  Argentina; Completed
      Instituto De Transplante De Medula OSEA, La Plata,  Argentina; Recruiting
      Fundaleu, Instituto de Transplante de Medula, Buenos Aires,  Argentina; Recruiting
      Sanatorio Mitre, Buenos Aires,  C1039AAN,  Argentina; Terminated
Australia
      Royal North Shore Hospital, Sydney,  2065,  Australia; Recruiting
      Westmead Hospital, Sydney,  Australia; Recruiting
      Royal Brisbane Hospital, Sydney,  Australia; Terminated
      Alfred Hospital, Sydney,  3141,  Australia; Recruiting
      Peter Maccalum Cancer Institute, Melbourne,  Australia; Recruiting
Austria
      University Clinic of Innsbruck, Innsbruck,  Austria; Recruiting
      University Clinic of Vienna, Vienna,  Austria; Completed
Belgium
      UZ Gasthuisberg, Leuven,  3000,  Belgium; Recruiting
      University Hospital Antwerp (UZA), Wilrijkstaat,  B-2650,  Belgium; Completed
Brazil
      Hospital Amaral Carvalho, Jau,  Brazil; Terminated
      Hospital De Clinicals Da Ufpr, Curitiba,  80060-900,  Brazil; No longer recruiting
      Hospital Amaral Carvalho, Jau,  Brazil; Completed
      Hospital Universitario Clementino Fraga Filho, Rio de Janeiro,  Brazil; Completed
      Hospital Das Clinicas Da Universidade de Marilia, Marilia,  17519-050,  Brazil; Completed
      UNICAMP, Campina,  Brazil; Completed
Canada
      Health Sciences Centre, Winnipeg,  R2A1R9,  Canada; Completed
      Hamilton Health Sciences Corporation - McMaster University, Hamilton,  Canada; Recruiting
      Hopital du Sacre-Coeur, Montreal,  H4J1C5,  Canada; Recruiting
      Hopital Maisonneuve-Rosemont, Montreal,  Canada; Completed
      Princess Margaret Hospital, Toronto,  Canada; Completed
Chile
      Hospital Luis Calvo Mackenna, Santiago,  Chile; Recruiting
Colombia
      Instituto De Cancerologia Clinica Las Americas, Medellin,  Colombia; Recruiting
      Instituto de Oncologia Carlos Ardilalulle, Bogota,  Colombia; Terminated
Czech Republic
      University Hospital Olomouc, Olomouc,  77520,  Czech Republic; Recruiting
Denmark
      Hematological Department 4241, Copenhagen,  Denmark; Recruiting
Dominican Republic
      Hospital Central De Las Fuerzas Armadas Y Policia N, Santo Domingo,  Dominican Republic; Recruiting
Ecuador
      Hospital IESS, Quito,  Ecuador; Recruiting
      Hospital SOLCA, Guayaquil,  Ecuador; Recruiting
      Cruz Roja Ecuatoriana, Quito,  Ecuador; Recruiting
El Salvador
      Hospital Rosales, San Salvador,  El Salvador; Recruiting
France
      C.H.R.U. de Lille, Hoptial Claude Huriez, Lille,  59037,  France; Completed
      Hopital Edouard Herriot, Lyon,  69437,  France; Completed
Germany
      Robert-Bosch-Krankenhaus, Stuttgart,  70376,  Germany; Completed
      Universitaet Koeln/Medizin. Klink I fuer Innere Medizin, Koeln,  Germany; Recruiting
      Klinikum der Johannes Gutenberg, Mainz,  Germany; Recruiting
      Robert-Bosch-Krankenhaus, Stuttgart,  70376,  Germany; Recruiting
Greece
      Peripheral University General Hospital, Patras,  Greece; Recruiting
      Peripheral General Hospital of Athens "G. Gennimates", Athens,  Greece; Recruiting
Guatemala
      Instituto Guatemalteco De Seguridad Social Hospital, ----,  01009,  Guatemala; Terminated
Hungary
      St. Laszlo Hospital, Budapest,  Hungary; Completed
Italy
      Ospedale La Maddalena, Palermo,  Italy; Completed
      Azienda Ospedaliera Pisana-Ospedale Santa Chiara, Pisa,  Italy; Recruiting
      P.O. Binaghi A.S.L. N., Cagliari,  Italy; Completed
      Osp Ferraroto, Catania,  Italy; Recruiting
      Policlinico Gemelli, Roma,  Italy; Completed
      Ospedale Niguarda-Ca Grande, Milano, Milano,  Italy; Recruiting
Mexico
      Centro Medico Nacional Siglo XXI I.M.S.S, Mexico City,  Mexico; Terminated
      Centro Medico Nacional20 de Noviembreissste, ------,  Mexico; Terminated
      Hospital Universitario Dr. J.E. Gonzalez, Monterrey,  64000,  Mexico; Recruiting
      Hospital de Especialidades, Mexico City,  02090,  Mexico; Recruiting
      Hospital Central Militar, Mexico City,  11200,  Mexico; Recruiting
Mexico, Mexico, D.F.
      Instituto Nacional de Ciencias Medicas y Nutricion, Tlalpan 14000, D.F.,  Mexico, D.F.,  14000,  Mexico; Recruiting
Netherlands
      Universitair Medisch Centrum Utrecht, Utrecht,  Netherlands; Completed
      Academisch Ziekenhuis, Groningen,  9713Z,  Netherlands; Completed
Panama
      Instituto Oncologico Nacional de Panama, Panama,  Panama; Completed
Peru
      Instituto Nacional De Enfermedades, Surquillo,  Peru; Completed
      Hospital Nacional Guillermo Almenara Irigoyen, Lima,  Peru; Recruiting
Poland
      Department of Hematology and BMT, Katowice,  Poland; Recruiting
Portugal
      Instituto Portugues de Oncologia-Lisboa, Lisboa,  Portugal; Recruiting
Puerto Rico
      University District Hospital, San Juan,  Puerto Rico; Recruiting
      Hospital Municipal de San Juan, San Juan,  009367314,  Puerto Rico; Completed
Singapore
      Singapore General Hospital, Singapore,  169608,  Singapore; Recruiting
South Africa
      Pretoria Academic Hospital - Oncology, Pretoria,  South Africa; Recruiting
Spain
      Hospital Universitario "Ramon Y Cajal", Madrid,  Spain; Completed
      Hospital Universitario de Salamanca, Salamanca,  Spain; Completed
      Hospital Universitario 12 de Octubre, Madrid,  Spain; Completed
      Hospital Clinic Provincial, Barcelona,  Spain; Completed
Sweden
      Huddinge Universitetssjukhus, Stockholm,  SE14186,  Sweden; Recruiting
      Akademiska Hospital, Uppsala,  Sweden; Recruiting
      Sahlgrenska University Hospital, Goteborg,  Sweden; Recruiting
United Kingdom
      Guy's Hospital, London,  United Kingdom; Completed
      Glasgow Royal Infirmary, Glasgow,  United Kingdom; Completed
      University Hospital of Wales, Cardiff,  United Kingdom; Recruiting

Study ID Numbers:  P01899
Record last reviewed:  November 2004
Record first received:  August 29, 2002
ClinicalTrials.gov Identifier:  NCT00044486
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10