EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

• Register: EUCTR
• Last refreshed on: 26 October 2020
• Main ID: EUCTR2013-000691-15-BE
• Date of registration: 22/08/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008
• Scientific 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
• Date of first enrolment: 26/09/2013
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000691-15
• Study type: Interventional clinical trial of medicinal product
• Study design: 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:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
Patients 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 patient (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. Patients still receiving bosutinib in either study B1871006 or B1871008;
b. Patients who have discontinued bosutinib but are still in the long term follow up phase of the study B1871006 or B1871008;
c. Patients from study B1871006 who have discontinued bosutinib and have already completed the long term follow up period.
3. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
4. Male and female patients of childbearing potential must agree to use 2 highly effective methods 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.
In order to be considered a female of non-childbearing potential the patient must meet at least 1 of the following criteria:
a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause or;
a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
c. Have medically confirmed and documented ovarian failure.
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
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:
Patients presenting with any of the following will not be included in the study:
1. Participation in other studies involving investigational drug(s) (Phases 1-4) while patient in the active treatment phase of the current study.
2. 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.
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 patient inappropriate for entry into this study.
4. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Myeloid Leukemia (CML)
MedDRA version: 20.0 Level: LLT Classification code 10009012 Term: Chronic myelogenous leukemia System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Bosulif 100 mg film-coated tablets
Product Name: Bosutinib - Clinical supply
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-

Trade Name: Bosulif 100 mg film-coated tablets
Product Name: Bosutinib - Commercial product
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-

Trade Name: Bosulif 500 mg film-coated tablets
Product Name: Bosutinib - Commercial product
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: 500-

Primary Outcome(s)

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, data to be collected, specifically efficacy data, are planned to be different in the first line CP patients relative to the later line and advanced patients.

For all patients 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 patients discontinue Bosutinib. (Samples collected for all patients except those enrolled at sites in China)
• Overall survival (OS);
• Fulfill the EMA post-approval requirement to compare the pharmacokinetic analysis of Ctrough of bosutinib in this study to Ctrough of previous studies. (Samples collected for all patients except those enrolled at sites in China)

For 2nd or later line patients coming from study B1871006 who are still 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.

Secondary Objective: Not applicable

Main Objective: • 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 (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 patients 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.

Timepoint(s) of evaluation of this end point: For CML 1st line patients coming from B1871008:
• AEs collected at = 28 days from last dose on parent study, at site month 3 & every 12 months, phone calls every 3 months, and = 28 days after last dose of bosutinib.
For CML 2nd and later line patients coming from B1871006:
• AEs collected at = 28 days from last dose on parent study, at site month 3 &every 6 months, phone calls every 3 months, and = 28 days after last dose of bosutinib.
For all patients:
• 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 until the last patient reaches 10 years from first dose (including parent study).

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

2013-000691-15-IT

B1871040

Source(s) of Monetary Support

Pfizer Inc

Ethics review

Status: Approved
Approval date: 20/09/2013
Contact: