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

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NCT00574873

Last updated on April 4, 2020
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Study Location
Pacific Cancer Medical Center Inc
Anaheim, California, 92801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00574873
Pfizer
Completed
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

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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/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
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 Center Pfizer
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

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