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Bosutinib 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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ClinicalTrials.gov Identifier: NCT01903733
Recruitment Status : Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: bosutinib Not Applicable

Expanded Access : Pfizer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Masking: None (Open Label)
Official Title: AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008
Actual Study Start Date : August 28, 2013
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020



Intervention Details:
  • Drug: bosutinib
    The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.


Primary Outcome Measures :
  1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML [ Time Frame: multiple years ]
    To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer-sponsored CML study (i.e., Studies B1871006 and B1871008) and who have the potential, as judged by the investigator, to derive clinical benefit from continued treatment with bosutinib



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.

Exclusion Criteria:

  • All subjects are excluded unless previously participating in studies B1871006 or B1871008.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903733


  Show 102 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01903733     History of Changes
Other Study ID Numbers: B1871040
2013-000691-15 ( EudraCT Number )
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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/data_requests.
Keywords provided by Pfizer:
Subjects
Chronic Myeloid Leukemia
CML
Bosutinib
Extension
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases