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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
City of Hope National Medical Center
Duarte, California, 91010 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

- 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)

NCT00261846
Pfizer
Completed
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

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Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Myeloid Leukemia
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
Experimental: SKI-606
Intervention: Drug: Bosutinib


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
571
August 6, 2015
September 25, 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00261846
3160A4-200
B1871006, 3160A4-200-WW
2005-004230-40 ( EudraCT Number )
B1871006 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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