| CTRI Number |
CTRI/2015/01/005461 [Registered on: 23/01/2015] Trial Registered Prospectively |
| Last Modified On: |
22/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Other |
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Public Title of Study
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A clinical trial to to collect long term safety and efficacy data for bosutinib in patients with Chronic Myelogenous Leukemia (CML). |
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Scientific Title of Study
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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 |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2013-000691-15 |
EudraCT |
| B1871040 Protocol dated 25 Feb 2013 |
Protocol Number |
| NCT01903733 |
ClinicalTrials.gov |
| US IND No.:68,268 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Seema Pai |
| Designation |
Director-India Cluster |
| Affiliation |
Pfizer Limited, |
| Address |
Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block,, Bandra Kurla Complex, Bandra East, Mumbai,MAHARASHTRA,400051, India
Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block,, Bandra Kurla Complex, Bandra East, Mumbai,MAHARASHTRA,400051, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
08826422322 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Seema Pai |
| Designation |
Director-India Cluster |
| Affiliation |
Pfizer Limited, |
| Address |
Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block,, Bandra Kurla Complex, Bandra East, Mumbai ,MAHARASHTRA,400051, India
Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block,, Bandra Kurla Complex, Bandra East, Mumbai ,MAHARASHTRA,400051, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
08826422322 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
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Source of Monetary or Material Support
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| Pfizer Limited, Pfizer Center, Patel Estate, SV road, Jogeshwari West, Mumbai 400102, India |
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Primary Sponsor
|
| Name |
Wyeth Pharmaceuticals India Private Limited |
| Address |
Level 6, Platina, Plot No. C-59. G-Block, Bandra-Kurla Complex, Bandra (East), Mumbai – 400 098, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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Argentina
Australia
Belgium
Brazil
Canada
Chile
China
Colombia
Finland
France
Germany
Hong Kong
Hungary
India
Italy
Japan
Latvia
Lithuania
Netherlands
Peru
Poland
Republic of Korea
Russian Federation
Singapore
South Africa
Spain
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anup Devasia |
Christian Medical College |
Christian Medical College, Department of Hematology, 1st Floor, Room No. 14, IDA Scudder Road, Vellore- 632 004, Tamil Nadu, India
Vellore
TAMIL NADU |
0416-2282352
dranupjdevasia@gmail.com |
| DrMadatha Vijay Ramanan |
Jehangir Clinical Development Centre Pvt. Ltd |
Department of Haemat-oncology, Ground Floor, Jehangir Clinical Development Centre Pvt. Ltd, Jehangir Hospital premises,32, Sassoon Road, Pune - 411001, Maharashtra, India
Pune
MAHARASHTRA |
09325315471
02026059319
mvijayr@gmail.com |
| DrNavin Khattry |
Tata Memorial Centre |
Tata Memorial Centre, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai-400012, Maharashtra, India
and
Tata Memorial Center, Advanced Center for Treatment, Research and Education in Cancer (ACTREC), Adult-Hematolymphoid
Department, 2nd Floor,Room number 247, Kharghar, Navi Mumbai - 410210,
Maharashtra, India
Mumbai
MAHARASHTRA |
09869451619
02227405126
nkhattry@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Review Board, |
Approved |
| Institutional Review Board, Tata Memorial Centre, Mumbai |
Submittted/Under Review |
| Jehangir Clinical Development Centre Institutional Review Board, Pune |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Chronic Myelogenous Leukemia (CML), |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Bosutinib, PF-05208763, formerly the legacy Wyeth compound SKI-606 |
Bosutinib, PF-05208763, 300 mg/400 mg/500 mg/600 mg orally once daily (QD).
Bosutinib is an orally bioavailable, potent, selective, dual Src-Abl TKI that has been developed as a tablet formulation for the treatment of adult subjects with Philadephia positive
(Ph+) chronic phase chronic myelogenous leukemia previously treated with other tyrosine kinase therapy.
Treatment will continue for up to 10 years (131 months of treatment, with one month of treatment equals to 28 days for study purposes) calculated from the first dose of bosutinib received on
the parent study unless disease progression, unacceptable toxicity, death, withdrawal of consent or Sponsor study discontinuation occurs. |
| Comparator Agent |
NA |
NA |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 stude 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.
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| ExclusionCriteria |
| Details |
Subjects presenting with any of the following will not be included in the study:
1. Participation in other studies involving investigational drug(s) (Phases 1-4) 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. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1.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
2.BCR -ABL mutations present at the time subjects discontinue bosutinib
3.Overall survival (OS) |
Disease status for pts is assessed according to local SOC.1st-line chronic phase pts will be followed for safety,survival&BCR-ABL mutation status,study visits-12months&phone visit-3months. 2nd&later line pts have visits-6months&phone visit-3months, At all visits emphasis will be on dosing compliance&patient safety.Efficacy assessed includes duration of hematologic&cytogenetic response,progression-free survival&time to transformation from accelerated to blast phase disease. |
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Secondary Outcome
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| Outcome |
TimePoints |
| Duration of hematologic and cytogenetic responses. |
NA |
| Progression free survival. |
NA |
| Time to transformation to accelerated or blast phase. |
NA |
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Target Sample Size
|
Total Sample Size="500"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
27/01/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2013 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="10"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
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Abstracts and publications from the data generated from the B1871040 are possible in the future. |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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This is an open-label bosutinib treatment extension protocol. This protocol will be offered to those bosutinib subjects who were previously enrolled in one of the two parent CML bosutinib studies (B1871006 or B1871008). Subjects to be enrolled will include those who – at the time of this protocol approval – are still receiving bosutinib in either one of the parent studies and are benefiting from bosutinib treatment as judged by the investigator, as well as those subjects who have already discontinued bosutinib as part of the parent studies and are in follow up for survival. The former group will continue to receive bosutinib as part of the extension study; the latter group will only enter into the long term survival follow up part of the extension study. In addition to that and in order to have the most accurate and unbiased statistical analysis of long term survival, the maximum number of subjects who have received bosutinib should be enrolled in the extension study including those who have completed the 2 years of follow-up as planned in the study B1871006 and then discontinued the study. For this purpose every efforts should be made to re-contact all the subjects who have completed the parent study B1871006 and offer themthe opportunity to participate in the extension study.
Each patient will remain in the extension study,either on Bosutinib treatment or in long-term survival follow-up phase,until the last patient has reached 10 years of follow-up, as calculated from the date of his/her first dose of Bosutinib administered in the parent study. After that period, the present study will be closed, and the subjects still benefiting from bosutinib will switch to the most appropriate therapy available at that time. |