Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

NCT00261846

Last updated date
Study Location
City of Hope National Medical Center
Duarte, California, 91010, United States
Contact
1-800-718-1021

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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

- Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.

- At least 3 months post stem cell transplantation

- Able to take daily oral capsules/tablets reliably

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


- Subjects with Philadelphia chromosome, and bcr-abl negative CML


- Overt leptomeningeal leukemia


- Subjects without evidence of leukemia in bone marrow (extramedullary disease only)

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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
  34. Cordoba, Prov. DE Cordoba
  35. Bahia Blanca, Provincia Buenos Aires
  36. Buenos Aires,
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  40. La Louviere,
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  43. Campinas/ SP,
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  47. Temuco,
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  49. Shanghai, P.R. China
  50. Beijing,
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  55. Bogota,
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  61. Nice Cedex 3,
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  70. Mannheim,
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  72. Shatin N.T.,
  73. Budapest,
  74. Gyor,
  75. Kaposvar,
  76. Nyiregyhaza,
  77. Mumbai, Maharashtra
  78. Mumbai, Maharashtra
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  80. Jaipur, Rajasthan
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  101. Tokyo,
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  124. Saint Petersburg,
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  126. St. Petersburg,
  127. Yaroslavl,
  128. Singapore,
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  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,
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  38. Adelaide, South Australia
  39. Adelaide,
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  44. Jardim Paulista, Sao Paulo/sp - Brazil
  45. Santo Andre, Sp - Brazil
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  50. Winnipeg, Manitoba
  51. Toronto, Ontario
  52. Montreal, Quebec
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  56. Beijing, P.r. China
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  58. Shanghai,
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  60. Bogota, Cundinamarca
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  65. Hamburg,
  66. Magdeburg,
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  68. Mainz,
  69. Mainz,
  70. Mainz,
  71. Mannheim,
  72. Chai Wan,
  73. Hong Kong,
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  75. Vellore, Tamil Nadu
  76. Bologna, Province of Bologna
  77. Orbassano, Torino
  78. Bologna,
  79. Monza,
  80. Seoul,
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  106. Uppsala,
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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
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  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,
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  90. Ankara,
  91. Cherkasy,
  92. Dnipropetrovsk,
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Official Title  ICMJE A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
Brief Summary This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Myeloid Leukemia
Intervention  ICMJE Drug: Bosutinib

Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.

Part 2, 500 mg oral, continuous, daily dosing.

Other Name: SKI-606
Study Arms  ICMJE Experimental: SKI-606
Intervention: Drug: Bosutinib
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: September 4, 2012)
571
Original Enrollment  ICMJE
 (submitted: December 2, 2005)
100
Actual Study Completion Date  ICMJE August 6, 2015
Actual Primary Completion Date September 25, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have disease progression/relapse while on full-dose imatinib, or are intolerant of any dose of imatinib.
  • At least 3 months post stem cell transplantation
  • Able to take daily oral capsules/tablets reliably

Exclusion Criteria:

  • Subjects with Philadelphia chromosome, and bcr-abl negative CML
  • Overt leptomeningeal leukemia
  • Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
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,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Colombia,   Finland,   Germany,   Hong Kong,   Hungary,   India,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00261846
Other Study ID Numbers  ICMJE 3160A4-200
B1871006, 3160A4-200-WW
2005-004230-40 ( EudraCT Number )
B1871006 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2017

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