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Safety And Efficacy Of Bosutinib (BLF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02501330
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : November 22, 2018
Information provided by (Responsible Party):

Brief Summary:

The objective of this surveillance is to collect information about

  1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
  2. the incidence of adverse drug reactions in this surveillance
  3. factors considered to affect the safety and/or efficacy of this drug.

Condition or disease Intervention/treatment
Chronic Myelogenous Leukemia Drug: Bosutinib

Detailed Description:
The patients should be registered by central registration system.

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Bosutinib For Cml (Post Marketing Commitment Plan)
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : September 22, 2023
Estimated Study Completion Date : September 22, 2023

Group/Cohort Intervention/treatment
Bosutinib Drug: Bosutinib
The usual adult dosage of once 500 mg per day postprandial oral administration as bosutinib. The dosage may be adjusted according to the patient's condition, but can be increased to once 600 mg 1 day.
Other Name: BOSULIF

Primary Outcome Measures :
  1. The incidence of adverse drug reactions [ Time Frame: 24 weeks ]
  2. Cytogenetic response [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients who have been treated with Bosutinib

Inclusion Criteria:

  • Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug

Exclusion Criteria:

  • Patients with a history of hypersensitivity
  • Women who may possibly be pregnant or become pregnant

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 identifier (NCT number): NCT02501330

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Contact: Pfizer Call Center 1-800-718-1021

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Shibuya-ku, Japan, 151-8589
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT02501330     History of Changes
Other Study ID Numbers: B1871036
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Keywords provided by Pfizer:
Drug use investigation in Japan

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases