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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pacific Cancer Medical Center Inc
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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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Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
A Phase 3 Randomized, Open-Label Study Of Bosutinib Versus Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myeloid Leukemia
  • 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
  • Experimental: 1
    Bosutinib
    Intervention: Drug: Bosutinib
  • Active Comparator: 2
    Imatinib
    Intervention: Drug: imatinib


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
502
May 2015
August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Croatia,   Puerto Rico,   Slovenia
 
NCT00574873
3160A4-3000
B1871008 ( Other Identifier: Alias Study Number )
2007-003780-50 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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