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Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

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ClinicalTrials.gov Identifier: NCT01903733
Recruitment Status : Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: bosutinib Not Applicable

Expanded Access : Pfizer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Masking: None (Open Label)
Official 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
Actual Study Start Date : August 28, 2013
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020



Intervention Details:
  • Drug: bosutinib
    The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.


Primary Outcome Measures :
  1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML [ Time Frame: multiple years ]
    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 (i.e., Studies B1871006 and B1871008) and who have the potential, as judged by the investigator, to derive clinical benefit from continued treatment with bosutinib



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.

Exclusion Criteria:

  • All subjects are excluded unless previously participating in studies B1871006 or B1871008.

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 ClinicalTrials.gov identifier (NCT number): NCT01903733


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Locations
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United States, Florida
Orlando Health, Inc.
Orlando, Florida, United States, 32806
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory University
Atlanta, Georgia, United States, 30322
Investigational Drug Service, Emory University Clinic
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Northside Hospital, Inc.- Central Research Department
Atlanta, Georgia, United States, 30342
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Indiana
Indiana Blood & Marrow Transplantation
Indianapolis, Indiana, United States, 46237
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States, 46237
United States, Iowa
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa, United States, 51101
United States, Maryland
Rcca Md,Llc
Bethesda, Maryland, United States, 20817
United States, New York
Hudson Valley Hematology and Oncology Associates
Hawthorne, New York, United States, 10532
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
The University of Texas MD Anderson Cancer Center- Investigational Pharmacy
Houston, Texas, United States, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Argentina
Instituto Medico Especializado Alexander Fleming
Cd. Autonoma De Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Hospital Italiano de la Plata
La Plata, Buenos Aires, Argentina, 1900
Hospital Dr. Jose Ramon Vidal
Corrientes,, Argentina, 3400
Australia, Queensland
The Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Belgium
GHDC (Grand Hopital de Charleroi)
Charleroi, Belgium, 6000
Brazil
Universidade Estadual de Campinas / Centro de Hematologia e Hemoterapia
Campinas, SP, Brazil, 13083-878
Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa em Hematologia e Oncologia (CEPHO)
Santo Andre, SP, Brazil, 09060-650
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Sir Mortimer B. Davis-Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Chile
Instituto Oncologico, Clinica Renaca
Renaca, V Region, Chile, 2540364
Instituto Oncologico Ltda
Renaca, V Region, Chile, 2540488
China, Zhejiang
The First affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
China
Peking Union Medical College Hospital
Beijing, China, 100730
Chinese People's Liberation Army General Hospital
Beijing, China, 100853
Ruijin Hospital- Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College
Tianjin, China, 300020
Colombia
Fundacion Santafe de Bogota
Bogota, Cundinamarca, Colombia, 110111
Finland
Helsingin Yliopistollinen Keskussairaala, Hematologian poliklinikka
Helsinki, Finland, 00290
HUS-Apteekki
Helsinki, Finland, 00290
HUS-Kuvantaminen
Helsinki, Finland, 00290
HUSLAB, Meilahden sairaalan laboratorio
Helsinki, Finland, 00290
France
CHU de CAEN
Caen Cedex 9, France, 14033
CHU Hotel Dieu - Service Hematologie
Nantes cedex 1, France, 44093
CHU de Poitiers
Poitiers Cedex, France, 86021
CHU Poitiers
Poitiers, France, 86021
Strasbourg Oncologie Liberale -Centre de Radiotherapie, Clinique St. Anne
Strasbourg, France, 67000
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
The Chinese University of Hong Kong-Prince Of Wales Hospital
Shatin, New Territories, Hong Kong
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
Budapest, Hungary, 1097
Somogy Megyei Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
Kaposvar, Hungary, 7400
India
Christian Medical College
Vellore, Tamil Nadu, India, 632 004
Italy
A.O.U. Policlinico S.Orsola Malpighi
Bologna, BO, Italy, 40138
Azienda Ospedaliera San Gerardo di Monza
Monza, MB, Italy, 20900
A.O.U. San Luigi Gonzaga di Orbassano
Orbassano, TO, Italy, 10043
Ospedale S. Eugenio - UOC Ematologia
Roma, Italy, 00144
Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi, Japan, 4418570
Akita University Hospital
Akita City, Akita, Japan, 010-8543
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 811-1395
Kanazawa University Hospital
Kanazawa-shi, Ishikawa, Japan, 920-8641
Kindai University Hospital
Osakasayama-city, Osaka, Japan, 589-8511
Osaka University Hopsital
Suita-city, Osaka, Japan, 565-0871
Osaka University Hospital
Suita-city, Osaka, Japan, 565-0871
Hamamatsu University School of Medicine University Hospital
Hamamatsu-shi, Shizuoka, Japan, 431-3192
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan, 113-8677
Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
Latvia
Riga East Clinical University Hospital
Riga, Latvia, LV-1079
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
University Medical Center Groningen, Department of Hematology
Groningen, Netherlands, 9713 GZ
Peru
Unidad de Investigacion de Hematologia - Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru, 11
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-124
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-501
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland, 20-081
Russian Federation
State Budgetary Institution of Rostov Region - Rostov Regional Clinical Hospital
Rostov-on-Don, Rostov Region, Russian Federation, 344015
State Budgetary Institution of Healthcare of Sverdlovsk Region
Ekaterinburg, Sverdlovsk Region, Russian Federation, 620102
Federal State Budgetary Institution
Moscow, Russian Federation, 125167
State Budgetary Educational Institution of Higher Professional Education
Rostov-on-Don, Russian Federation, 344022
State Budgetary Institution of Healthcare - Leningrad Regional Clinical Hospital
Saint Petersburg, Russian Federation, 194291
Clinic "Institute of Pediatric Oncology, Hematology and Transplantation n.a. R.M. Gorbachova"
Saint Petersburg, Russian Federation, 197022
Federal State Budgetary Institution "Federal Almazov Medical Research Centre"
Saint Petersburg, Russian Federation, 197341
State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin
Samara, Russian Federation, 443095
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
South Africa
Wits Clinical Research-Chris Hani Baragwanath Hospital
Soweto, Gauteng, South Africa, 2013
Spain
Hospital Universitari Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Hospital Virgen de la Salud
Toledo, Spain, 45004
Hospital Clinico Universitario De Valencia (CHUV)
Valencia, Spain, 46010
Thailand
Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,
Bangkok, Thailand, 10700
Turkey
Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
Gaziantep, Sehit Kamil, Turkey, 27310
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey, 06100
Ukraine
Municipal Institution "Cherkasy Regional Oncology Dispensary"
Cherkasy, Ukraine, 18009
MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" of DRC Hematology Center
Dnipropetrovsk, Ukraine, 49102
Clinical and diagnostic production laboratory
Kyiv, Ukraine, 01103
Laboratory of Immunogenetics
Kyiv, Ukraine, 03115
State Institution "National Research Center for Radiation Medicine of the National Academy of
Kyiv, Ukraine, 03115
SI Institute of Hematology and Transfusiology of National Academy of Medical Sciences of Ukraine
Kyiv, Ukraine, 04112
State Institution "Institute of Blood Pathology and Transfusion Medicine of
Lviv, Ukraine, 79044
United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PG
Freeman Hospital
Newcastle Upon Tyne, UK, United Kingdom, NE7 7DN
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01903733     History of Changes
Other Study ID Numbers: B1871040
2013-000691-15 ( EudraCT Number )
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
Subjects
Chronic Myeloid Leukemia
CML
Bosutinib
Extension
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases