Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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24 March 2014 |
Main ID: |
EUCTR2013-000691-15-LT |
Date of registration:
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29/05/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008
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Scientific title:
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AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008 |
Date of first enrolment:
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11/07/2013 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000691-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: extension study - phase is N/A
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Canada
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Chile
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China
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Colombia
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Finland
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France
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Germany
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Hong Kong
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Hungary
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India
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Italy
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Japan
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Netherlands
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Peru
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Poland
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Russian Federation
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Singapore
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South Africa
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Spain
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Thailand
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 E 42nd Street
NY 10017
New York
United States |
Telephone:
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+1800 7181021 |
Email:
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ClinicalTrials.gov.CallCenter@pfizer.com |
Affiliation:
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Pfizer Inc |
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 E 42nd Street
NY 10017
New York
United States |
Telephone:
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+1800 7181021 |
Email:
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ClinicalTrials.gov.CallCenter@pfizer.com |
Affiliation:
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Pfizer Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
2. Previous enrollment in the bosutinib arm of one of the two Pfizer parent studies: B1871006 or B1871008. This includes:
a. Subjects still receiving bosutinib in either study B1871006 or B1871008;
b. Subjects who have discontinued bosutinib but are still in the long term follow up phase of the study B1871006 or B1871008;
c. Subjects from study B1871006 who have discontinued bosutinib and have already completed the long term follow up period.
3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria: Subjects presenting with any of the following will not be included in the study:
1. Participation in other studies involving investigational drug(s) (Phases 1 to 4) while subject in the active treatment phase of the current study.
2. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
3. Other severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
4. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 30 days after last dose of investigational product.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Myeloid Leukemia (CML) MedDRA version: 14.1
Level: LLT
Classification code 10009012
Term: Chronic myelogenous leukemia
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: Bosulif 100 mg film-coated tablets Product Name: Bosutinib Product Code: PF-05208763; SKI-606 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bosutinib CAS Number: 380843-75-4 Current Sponsor code: PF-05208763; SKI-606 Other descriptive name: SKI-606 monohydrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Main Objective: • To allow long term bosutinib treatment in subjects with chronic or advanced phases Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (ie, studies B1871006 and B1871008) and who have the potential, as judged by the investigator, to derive clinical benefit from continued treatment with bosutinib; • To collect long term safety and efficacy data for bosutinib; • To assess the duration of clinical benefit for Ph+ CML subjects treated with bosutinib; • To fulfill the European Medicines Agency (EMA) post approval requirement for the collection and analysis of safety data about diarrhea incidence after switch from clinical study to commercial bosutinib formulation.
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Primary end point(s): 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. In addition, study endpoints to be reported and data to be collected, specifically efficacy data, are planned to be different in the first line CP subjects relative to the later line and advanced subjects.
For all subjects regardless of the line of treatment: • Long term safety of bosutinib, including type, incidence, severity, timing, seriousness and relatedness of AEs and laboratory abnormalities as well as reason of treatment discontinuation. A special focus will be made on diarrhea in order to satisfy the EMA post commitment request; • BCR ABL mutations present at the time subjects discontinue bosutinib; • Overall survival (OS),
For 2nd or later line subjects coming from study B1871006: as long as subjects are on treatment with bosutinib, the following efficacy endpoints will be assessed: • Duration of hematologic and cytogenetic responses; • Progression free survival; • Time to transformation to accelerated or blast phase.
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Secondary Objective: Not applicable
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Timepoint(s) of evaluation of this end point: For CML 1st line subjects coming from B1871008: • AEs collected at = 28 days from last dose on parent study, at site visit at month 3, every 12 months, at phone calls every 3 months, and at = 28 days after last dose of bosutinib. For CML 2nd and later line subjects coming from B1871006: • AEs collected at = 28 days from last dose on parent study, at site visit at month 3, at every 6 months, at phone calls every 3 months, and at = 28 days after last dose of bosutinib. For all subjects: • Diarrhea information collected at = 28 days from last dose on parent study and at month 3 site visit. • BCR ABL mutation analysis at = 28 days after last dose of bosutinib. • Survival follow-up at every 3 months from last dose of bosutinib for up to 10 years from first dose (including parent study).
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Not applicable
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Secondary end point(s): Not applicable
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Secondary ID(s)
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B1871040
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2013-000691-15-IT
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Source(s) of Monetary Support
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Pfizer Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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