Clinical trial NCT01903733: Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Myeloid Leukemia
Keywords: Subjects
Chronic Myeloid Leukemia
CML
Bosutinib
Extension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)
timeFrame: From first dose of drug up to 30 days after last dose (up to approximately 14 years)
measure: Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)
timeFrame: From first dose of drug up to 30 days after last dose (up to approximately 14 years)
measure: Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)
timeFrame: From first dose of drug up to 30 days after last dose (up to approximately 14 years)
measure: Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03)
timeFrame: From first dose of drug up to 30 days after last dose (up to approximately 14 years)
measure: Number of Participants With Adverse Events as Reason for Treatment Discontinuation
timeFrame: From first dose of drug up to 30 days after last dose (up to approximately 14 years)
measure: Number of Participants With Diarrhea After Switch From Bosutinib Clinical Formulation to Bosutinib Commercial Formulation
timeFrame: Last 6 months on clinical formulation and first 6 months on commercial formulation
measure: Number of Participants With Breakpoint Cluster Region Abelson Protooncogene (BCR-ABL) Mutations Present at Time of Bosutinib Treatment Discontinuation
timeFrame: Post-baseline on Day 1 (maximum up to 14 years)
measure: Overall Survival (OS) Rate at Year 10
timeFrame: Year 10
measure: Plasma Steady-State Trough Concentrations (Ctrough) of Bosutinib
timeFrame: One pre-dose sample was collected at the first scheduled visit (after approval and implementation of protocol amendment 1) following at least 2 weeks of uninterrupted dosing at the same dose level
measure: Kaplan-Meier Estimate of Probability of Maintaining Major Cytogenetic Response (MCyR) at Year 10: B1871006 Participants
timeFrame: Year 10
measure: Kaplan-Meier Estimate of Probability of Maintaining Complete Cytogenetic Response (CCyR) at Year 10: B1871006 Participants
timeFrame: Year 10
measure: Kaplan-Meier Estimate of Probability of Maintaining Complete Hematologic Response (CHR) at Year 10: B1871006 Participants
timeFrame: Year 10
measure: Cumulative Incidence of Progression/Death Events at Year 10: B1871006 Participants
timeFrame: Year 10
measure: Cumulative Incidence of Rate of Transformation to Accelerated Phase (AP) or Blast Phase (BP) at Year 10: B1871006 Participants
timeFrame: Year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital Inc., - GCS/Northside
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital, Inc. - Central Research Department
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation
state: Indiana
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Bethesda
country: United States
facility: Rcca Md,Llc
state: Maryland
city: Hawthorne
country: United States
facility: Hudson Valley Hematology and Oncology Associates
state: New York
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas, MD Anderson Cancer Center
state: Texas
city: Cd. Autonoma De Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de la Plata
state: Buenos Aires
city: Corrientes
country: Argentina
facility: Hospital Dr. Jose Ramon Vidal
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Charleroi
country: Belgium
facility: GHDC (Grand Hopital de Charleroi)
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas / Centro de Hematologia e Hemoterapia
state: SP
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa em Hematologia e Oncologia (CEPHO)
state: SP
city: Edmonton
country: Canada
facility: Alberta Health Services - Department of Medical Oncology - Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis-Jewish General Hospital
state: Quebec
city: Renaca
country: Chile
facility: Instituto Oncologico, Clinica Renaca
state: V Region
city: Renaca
country: Chile
facility: Instituto Oncologico
state: V Region
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Hangzhou
country: China
facility: The First affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Shanghai
country: China
facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine
city: Tianjin
country: China
facility: Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota
state: Cundinamarca
city: Helsinki
country: Finland
facility: Helsingin Yliopistollinen Keskussairaala, Hematologian poliklinikka
city: Caen Cedex 9
country: France
facility: CHU de CAEN
city: Nantes cedex 1
country: France
facility: CHU Hotel Dieu - Service Hematologie
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
city: Poitiers
country: France
facility: CHU Poitiers
city: Strasbourg
country: France
facility: Strasbourg Oncologie Liberale -Centre de Radiotherapie, Clinique Ste Anne
city: Chai Wan
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly
city: Vellore
country: India
facility: Christian Medical College. Vellore
state: Tamil NADU
city: Bologna
country: Italy
facility: A.O.U. Policlinico S.Orsola Malpighi
state: BO
city: Monza
country: Italy
facility: ASST Monza - Ospedale san Gerardo
state: Monza AND Brianza
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga di Orbassano
state: TO
city: Roma
country: Italy
facility: Ospedale S. Eugenio - UOC Ematologia
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Akita City
country: Japan
facility: Akita University Hospital
state: Akita
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Osakasayama-city
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-city
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University School of Medicine University Hospital
state: Shizuoka
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Department of Hematology
city: Lima
country: Peru
facility: Unidad de Investigacion de Hematologia - Hospital Nacional Edgardo Rebagliati Martins
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Sverdlovsk Region
state: Sverdlovsk Region
city: Moscow
country: Russian Federation
facility: Federal State-Funded Institution National Research Center of Hematology of the Ministry of
city: Rostov-on-Don
country: Russian Federation
facility: State Budgetary Institution of Rostov Region - Rostov Regional Clinical Hospital
city: Rostov-on-Don
country: Russian Federation
facility: State Budgetary Educational Institution of Higher Professional Education
city: Saint Petersburg
country: Russian Federation
facility: State Budgetary Institution of Healthcare - Leningrad Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Clinic "Institute of Pediatric Oncology, Hematology and Transplantation n.a. R.M. Gorbachova"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "Federal Almazov Medical Research Centre"
city: Samara
country: Russian Federation
facility: State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Soweto
country: South Africa
facility: Wits Clinical Research-Chris Hani Baragwanath Hospital
state: Gauteng
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara Campal
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia (CHUV)
city: Bangkok
country: Thailand
facility: Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
state: Sehit Kamil
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Cherkasy
country: Ukraine
facility: Municipal Institution "Cherkasy Regional Oncology Dispensary"
city: Dnipropetrovsk
country: Ukraine
facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" of DRC Hematology Center
city: Kyiv
country: Ukraine
facility: State Institution "National Research Center for Radiation Medicine of the National Academy of
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #9, SI "Institute of Hematology and Transfusiology of NAMS of Ukraine"
city: Lviv
country: Ukraine
facility: State Institution "Institute of Blood Pathology and Transfusion Medicine of
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottinhgam
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.