Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

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NCT00574873

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Study Location
Pacific Cancer Medical Center Inc
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.

- Diagnosis of CML chronic phase confirmed.

- Adequate hepatic and renal function.

- Able to take oral tablets.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Exclusions include Philadelphia negative CML.


- Prior anti-leukemia treatment.


- Prior stem cell transplant.

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Chronic Myeloid LeukemiaCompare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML NCT00574873
  1. Anaheim, California
  2. Beverly Hills, California
  3. Fountain Valley, California
  4. La Jolla, California
  5. La Jolla, California
  6. San Diego, California
  7. Stanford, California
  8. Stanford, California
  9. Stanford, California
  10. Hudson, Florida
  11. New Port Richey, Florida
  12. New Port Richey, Florida
  13. Orlando, Florida
  14. Tarpon Springs, Florida
  15. Atlanta, Georgia
  16. Indianapolis, Indiana
  17. Indianapolis, Indiana
  18. Sioux City, Iowa
  19. Salinas, Kansas
  20. Wichita, Kansas
  21. Hazard, Kentucky
  22. Bethesda, Maryland
  23. Brownstown, Michigan
  24. Dearborn, Michigan
  25. Detroit, Michigan
  26. Detroit, Michigan
  27. Cherry Hill, New Jersey
  28. Cherry Hill, New Jersey
  29. Somerville, New Jersey
  30. Farmington, New Mexico
  31. Chattanooga, Tennessee
  32. Houston, Texas
  33. La Plata, Buenos Aires
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  66. Berlin,
  67. Dresden,
  68. Hamburg,
  69. Leipzig,
  70. Mannheim,
  71. Muenchen,
  72. Shatin N.T.,
  73. Budapest,
  74. Gyor,
  75. Kaposvar,
  76. Nyiregyhaza,
  77. Mumbai, Maharashtra
  78. Mumbai, Maharashtra
  79. Pune, Maharashtra
  80. Jaipur, Rajasthan
  81. Jaipur, Rajasthan
  82. Monza, Lombardia
  83. Orbassano, Torino
  84. Catania,
  85. Roma,
  86. Toyohashi, Aichi
  87. Akita City, Akita
  88. Fukuoka-Shi, Fukuoka
  89. Kanazawa, Ishikawa
  90. Sendai, Miyagi
  91. Osakasayama, Osaka
  92. Komae-shi, Tokyo
  93. Aichi,
  94. Aichi,
  95. Chiba,
  96. Kanagawa,
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  112. Barnaul,
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  128. Singapore,
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  140. Changhua City,
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  142. Bangkoknoi, Bangkok
  143. Ankara, Sihhiye
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  154. Kyiv,
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  159. Nottingham, EAST Midlands
  160. Nottingham, EAST Midlands
  161. Hammersmith, London
  162. Birmingham, WEST Midlands
  163. Birmingham, WEST Midlands
  164. Leeds, WEST Yorkshire
  165. London,
  166. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Chronic Myeloid LeukemiaStudy Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias NCT00261846
  1. Duarte, California
  2. Denver, Colorado
  3. Denver, Colorado
  4. Washington, D.C., District of Columbia
  5. Atlanta, Georgia
  6. Atlanta, Georgia
  7. Atlanta, Georgia
  8. Niles, Illinois
  9. Indianapolis, Indiana
  10. Shreveport, Louisiana
  11. Baltimore, Maryland
  12. Baltimore, Maryland
  13. Buffalo, New York
  14. Hawthorne, New York
  15. Hawthorne, New York
  16. Hawthorne, New York
  17. New York, New York
  18. New York, New York
  19. Rochester, New York
  20. Rochester, New York
  21. Rochester, New York
  22. Rochester, New York
  23. Rochester, New York
  24. Valhalla, New York
  25. Hershey, Pennsylvania
  26. Houston, Texas
  27. Houston, Texas
  28. Houston, Texas
  29. Richmond, Virginia
  30. La Plata, Provincia de Buenos Aires
  31. Buenos Aires,
  32. Buenos Aires,
  33. Buenos Aires,
  34. Ciudad Autonoma de Buenos Aires,
  35. Corrientes,
  36. Corrientes,
  37. Pcia de Buenos Aires,
  38. Adelaide, South Australia
  39. Adelaide,
  40. Melbourne,
  41. Queensland,
  42. Queensland,
  43. Wels,
  44. Jardim Paulista, Sao Paulo/sp - Brazil
  45. Santo Andre, Sp - Brazil
  46. Sao Paulo, Sp Brazil
  47. Curitiba, PR,
  48. Edmonton, Alberta
  49. Kelowna, British Columbia
  50. Winnipeg, Manitoba
  51. Toronto, Ontario
  52. Montreal, Quebec
  53. Temuco,
  54. Zhejiang, P.r China
  55. Beijing, P.r. China
  56. Beijing, P.r. China
  57. Tianjin, P.r. China
  58. Shanghai,
  59. Medellin, Antioquia
  60. Bogota, Cundinamarca
  61. Helsinki,
  62. Mainz, RP
  63. Dresden,
  64. Hamburg,
  65. Hamburg,
  66. Magdeburg,
  67. Mainz,
  68. Mainz,
  69. Mainz,
  70. Mainz,
  71. Mannheim,
  72. Chai Wan,
  73. Hong Kong,
  74. Budapest,
  75. Vellore, Tamil Nadu
  76. Bologna, Province of Bologna
  77. Orbassano, Torino
  78. Bologna,
  79. Monza,
  80. Seoul,
  81. Seoul,
  82. Nuevo Leon,
  83. Toluca Estado de Mexico,
  84. Amsterdam,
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  88. The Netherlands,
  89. Trondheim, Norge
  90. Lima,
  91. Ekaterinburg,
  92. Kirov,
  93. Moscow,
  94. Moscow,
  95. Rostov-on Don,
  96. Saint Petersburg,
  97. Singapore,
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  100. Parktown,
  101. Soweto,
  102. Barcelona, Catalonia
  103. Barcelona, Catalonia
  104. Madrid,
  105. Valencia,
  106. Uppsala,
  107. Taipei 100,
  108. Newcastle Upon Tyne, North East England
  109. University upon Tyne, North East England
  110. London,
  111. Newcastle Upon Tyne, North East England,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Chronic Myeloid LeukemiaBosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008 NCT01903733
  1. Orlando, Florida
  2. Atlanta, Georgia
  3. Atlanta, Georgia
  4. Atlanta, Georgia
  5. Sandy Springs, Georgia
  6. Indianapolis, Indiana
  7. Indianapolis, Indiana
  8. Sioux City, Iowa
  9. Bethesda, Maryland
  10. Bethesda, Maryland
  11. Hawthorne, New York
  12. Hershey, Pennsylvania
  13. Houston, Texas
  14. Houston, Texas
  15. Houston, Texas
  16. Cd. Autonoma De Buenos Aires, Buenos Aires
  17. La Plata, Buenos Aires
  18. Corrientes,,
  19. Herston, Queensland
  20. Adelaide, South Australia
  21. Charleroi,
  22. Campinas, SP
  23. Santo Andre, SP
  24. Edmonton, Alberta
  25. Vancouver, British Columbia
  26. Toronto, Ontario
  27. Montreal, Quebec
  28. Renaca, V Region
  29. Renaca, V Region
  30. Beijing, Beijing
  31. Hangzhou, Zhejiang
  32. Beijing,
  33. Shanghai,
  34. Tianjin,
  35. Bogota, Cundinamarca
  36. Helsinki,
  37. Helsinki,
  38. Helsinki,
  39. Helsinki,
  40. Caen Cedex 9,
  41. Nantes cedex 1,
  42. Poitiers Cedex,
  43. Poitiers,
  44. Strasbourg,
  45. Chai Wan,
  46. Shatin, New Territories,
  47. Budapest,
  48. Kaposvar,
  49. Vellore, Tamil Nadu,
  50. Bologna, BO
  51. Monza, Monza AND Brianza
  52. Orbassano, TO
  53. Roma,
  54. Toyohashi, Aichi
  55. Akita City, Akita
  56. Fukuoka-shi, Fukuoka
  57. Kanazawa-shi, Ishikawa
  58. Osakasayama-city, Osaka
  59. Suita-city, Osaka
  60. Suita-city, Osaka
  61. Hamamatsu-shi, Shizuoka
  62. Tokyo,
  63. Seoul,
  64. Riga,
  65. Amsterdam,
  66. Groningen,
  67. Lima,
  68. Gdansk,
  69. Gdańsk,
  70. Krakow,
  71. Lublin,
  72. Rostov-on-Don, Rostov Region
  73. Ekaterinburg, Sverdlovsk Region
  74. Moscow,
  75. Rostov-on-Don,
  76. Saint Petersburg,
  77. Saint Petersburg,
  78. Saint Petersburg,
  79. Samara,
  80. Singapore,
  81. Soweto, Gauteng
  82. Barcelona,
  83. Madrid,
  84. Madrid,
  85. Madrid,
  86. Toledo,
  87. Valencia,
  88. Bangkok,
  89. Gaziantep, Sehit Kamil
  90. Ankara,
  91. Cherkasy,
  92. Dnipropetrovsk,
  93. Kyiv,
  94. Kyiv,
  95. Lviv,
  96. Newcastle Upon Tyne, UK
  97. Nottinhgam,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
Official Title  ICMJE A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA
Brief Summary Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Myeloid Leukemia
Intervention  ICMJE
  • Drug: Bosutinib
    500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
    Other Name: SKI 606
  • Drug: imatinib
    400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.
    Other Name: Gleevec
Study Arms  ICMJE
  • Experimental: 1
    Bosutinib
    Intervention: Drug: Bosutinib
  • Active Comparator: 2
    Imatinib
    Intervention: Drug: imatinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2012)		502
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)		412
Actual Study Completion Date  ICMJE May 27, 2015
Actual Primary Completion Date August 31, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
  • Diagnosis of CML chronic phase confirmed.
  • Adequate hepatic and renal function.
  • Able to take oral tablets.

Exclusion Criteria:

  • Exclusions include Philadelphia negative CML.
  • Prior anti-leukemia treatment.
  • Prior stem cell transplant.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   France,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Croatia,   Puerto Rico,   Slovenia
 
Administrative Information
NCT Number  ICMJE NCT00574873
Other Study ID Numbers  ICMJE 3160A4-3000
B1871008 ( Other Identifier: Alias Study Number )
2007-003780-50 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP