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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28 June 2021 |
Main ID: |
EUCTR2013-003250-25-BE |
Date of registration:
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26/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Bosutinib in Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with one or two more Tyrosine Kinase Inhibitors
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Scientific title:
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A Phase 4 Safety and Efficacy Study of Bosutinib (Bosulif®) in Patients with Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with One or More Tyrosine Kinase Inhibitors |
Date of first enrolment:
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11/06/2014 |
Target sample size:
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165 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003250-25 |
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: Post Marketing Study for Safety and Efficacy If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Austria
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Belgium
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Finland
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France
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Germany
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Italy
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Netherlands
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Norway
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Spain
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Sweden
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United States
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Contacts
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Name:
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Clinical Trials.gov Call Centre
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Address:
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235 E 42nd Street
NY, 10017
New York
United States |
Telephone:
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+1800718 1021 |
Email:
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ClinicalTrials.govCallCentre@pfizer.com |
Affiliation:
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Pfizer Inc |
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Name:
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Clinical Trials.gov Call Centre
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Address:
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235 E 42nd Street
NY, 10017
New York
United States |
Telephone:
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+1800718 1021 |
Email:
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ClinicalTrials.govCallCentre@pfizer.com |
Affiliation:
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Pfizer Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Cytogenetic or PCR-based diagnosis of Ph+ CML or BCR-ABL1+ if Ph- (from initial diagnosis). NOTE: Ph- subjects will not count towards the 150 patients for primary and secondary analyses, which include Ph+ patients only.
2. Prior treatment with 1 or more TKIs for CML.
3. Any CML phase, as long as the patient is resistant to, intolerant of, or otherwise not appropriate for treatment with imatinib, dasatinib and/or nilotinib.
4. ECOG Performance Status of 0 or 1 for CP patients, or 0, 1, 2, or 3 for 4th line CP (and beyond) and AP/ BP patients.
5. Adequate bone marrow function:
For 2nd and 3rd line CP CML patients:
(1) Absolute neutrophil count >1000/mm3 (>1 x109/L).
(2) Platelets =75,000/mm3 (=75 x109/L) absent any platelet transfusions during the preceding 14 days.
For 4th line CP and AP/BP CML patients:
(1) Absolute neutrophil count >500/mm3 (>0.5 x109/L).
(2) Platelets =50,000/mm3 (=50 x109/L) absent any platelet transfusions during the preceding 14 days.
6. Adequate hepatic and renal function:
(a) AST/ALT =2.5 x ULN or ALT/AST =5 x ULN if attributable to liver involvement of leukaemia.
(b) Total direct bilirubin =1.5 x ULN.
(c) Creatinine =1.5 x ULN.
7. Able to take daily oral tablets.
8. Age =18 years.
9. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legal representative) has been informed of all pertinent aspects of the study.
10. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
11. Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A patient 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 132 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria: 1. Participation in other studies involving investigational drug(s) (Phase 1-4) within 14
days or 3 half-lives (whichever is longer) prior to the first dose of bosutinib.
2. Prior bosutinib exposure.
3. Prior ponatinib exposure.
4. Known T315I or V299L mutation in BCR-ABL1.
5. Clinically active leptomeningeal leukemia. Patients must be free of central nervous system (CNS) involvement for a minimum of 2 months.
6. Hypersensitivity to the active substance or to any of the following excipients:
Microcrystalline cellulose (E460), Croscarmellose sodium (E468), Poloxamer 188, Povidone (E1201), Magnesium stearate (E470b), Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc (E553b), Iron oxide red (E172).
7. Pregnant or breastfeeding females.
8. Males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
9. 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 patient inappropriate for entry into this study.
10. Patients 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 patients who are Pfizer employees directly involved in the conduct of the trial.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Philadelphia Chromosome Positive Chronic Myeloid Leukaemia MedDRA version: 17.1
Level: PT
Classification code 10009013
Term: Chronic myeloid leukaemia
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Trade Name: Bosulif Pharmaceutical Form: Tablet INN or Proposed INN: Bosutinib Other descriptive name: BOSUTINIB MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Bosulif Pharmaceutical Form: Tablet INN or Proposed INN: Bosutinib Other descriptive name: BOSUTINIB MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
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Primary Outcome(s)
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Main Objective: Primary Objectives •To estimate the 1-year (Week 52) probability of cumulative Major Cytogenetic Response (MCyR) in CP Ph+ CML patients with 1 or 2 prior lines of TKI therapy. •To estimate the 1-year (Week 52) probability of cumulative MCyR in CP Ph+ CML patients with 3 or more prior lines of TKI therapy. •To estimate the 1-year (Week 52) probability of cumulative confirmed Overall Hematological Response (OHR) in AP and BP Ph+ CML patients with any prior TKI therapy.
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Primary end point(s): (1) Cumulative MCyR by 1 year (52 weeks) in 2nd and 3rd line CP patients. (2) Cumulative MCyR by 1 year (52 weeks) in 4th and later line CP patients. (3) Cumulative confirmed OHR by 1 year (52 weeks) in AP and BP patients.
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Secondary Objective: •To estimate the probability of cumulative MCyR in each disease phase (CP, AP and BP) for Ph+ CML patients. •To estimate the probability of cumulative confirmed OHR in each disease phase (AP and BP) for Ph+ CML patients by number of lines of prior therapy. •To characterize the distributions of best response (molecular, cytogenetic, or hematologic) in the CP, AP, and BP Ph+ CML patient populations. •To estimate the probability of MCyR at 3, 6, 12, 18, and 24 months in the CP, AP, and BP Ph+ CML patient populations. •To estimate the probability of confirmed OHR at 3, 6, 9, 12, 18, and 24 months in the AP and BP Ph+ CML patient populations. •To estimate the probability of cumulative confirmed Complete Hematological Response (CHR) in the CP, AP and BP Ph+ CML patient populations. •To estimate the probability of cumulative major molecular response (MMR) in the CP, AP and BP Ph+ CML patient populations. •To evaluate the overall safety profile of bosutinib in the study population.
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Timepoint(s) of evaluation of this end point: 1 year (52 weeks)
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Secondary Outcome(s)
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Secondary end point(s): (1) Cumulative MCyR in CP, AP and BP patients.
(2) Cumulative confirmed OHR in AP and BP patients by line of therapy.
(3) Cumulative best response in CP, AP, and BP patients.
(4) MCyR at 3, 6, 12, 18, and 24 months in CP, AP, and BP patients.
(5) Confirmed OHR at 3, 6, 9, 12, 18, and 24 months in AP and BP patients.
(6) Cumulative confirmed CHR.
(7) Cumulative MMR in CP, AP, and BP patients.
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Timepoint(s) of evaluation of this end point: Various timepoints mainly 3, 6, 12, 18 and 24 months. See Table 1, schedule of activities in protocol.
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Secondary ID(s)
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2013-003250-25-SE
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B1871039
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Source(s) of Monetary Support
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Pfizer Inc, 235 East 42nd Street, New York, NY 10017
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Ethics review
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Status: Approved
Approval date: 11/06/2014
Contact:
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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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