Spots Global Cancer Trial Database for Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
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Trial Identification
Brief Title: Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
Official Title: A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
Study ID: NCT02467270
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by \<=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.
Detailed Description: The drug being tested in this study is ponatinib. This study will characterize the safety and efficacy of ponatinib over a range of 3 starting doses. The study will enroll 276 participants in 3 cohorts and each cohort will have 92 participants. All the participants will be randomized to receive once-daily oral administration of 1 of 3 starting doses of ponatinib: * Cohort A: 45 mg ponatinib tablet * Cohort B: 30 mg ponatinib tablet * Cohort C: 15 mg ponatinib tablet The study is designed to consist of 2 periods: 24-cycle Main treatment period and optional treatment continuation period. Participants will be treated with their randomized dose of study drug in the Main Treatment Period until the occurrence of at least one of the following: absence of CHR by 3 months, absence of MCyR at 12 months, absence of \<=1% BCR-ABL1IS at 12 months, loss of \<=1% BCR-ABL1IS development of intolerance, or completion of all 24 cycles of treatment (whichever occurs first). Following completion of approximately 5 years or following early withdrawal, participants may enter into an optional treatment continuation period. This multi-center trial will be conducted in the United States, United Kingdom, Republic of Korea, Spain, France, Taiwan, Australia, Canada, Italy, Chile, Japan, Germany, Argentina, Poland, Czech Republic, Denmark, Hong Kong, Portugal, Russia, Singapore, Switzerland, and Sweden. The overall time to participate in this study is approximately 96 months. Participants will make a final visit to the clinic approximately 30 days after the last dose of study treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Indiana Blood & Marrow Transplantation, Indianapolis, Indiana, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Michigan Medicine, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota Medical School, Minneapolis, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center - New York, New York, New York, United States
NewYork-Presbyterian Weill Cornell Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic Taussig Cancer Institute Main Campus, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Abramson Cancer Center, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fundaleu, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital General de Agudo Jose Maria Ramos Mejia, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano La Plata, La Plata, Buenos Aires, Argentina
Royal North Shore Hospital, Saint Leonards, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Princess Margaret Hospital - Toronto, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Saskatchewan Cancer Agency, Regina, Saskatchewan, Canada
Hospital del Salvador, Providencia, Santiago, Chile
Centro de Investigaciones Clinicas Vina del Mar, Vina del Mar, Valparaiso, Chile
Ustav Hematologie a Krevni Transfuze Praha, Prague, Praha, Czechia
Fakultni Nemocnice Olomouc, Olomouc, , Czechia
Aarhus University Hospital, Aarhus C, \Aarhus, Denmark
Centre de Lutte Contre le Cancer - Institut Bergonie, Bordeaux, Aquitaine, France
Centre Hospitalier Universitaire de Nancy Hopital de Brabois, Vandoeuvre les Nancy, Lorraine, France
Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse Cedex 9, Midi-pyrenees, France
Centre Hospitalier Regional Universitaire de Lille, Lille cedex, NORD Pas-de-calais, France
Center Hospitalier Universitaire d'Angers, Angers Cedex 9, PAYS DE LA Loire, France
Centre Hospitalier Universitaire de Nantes Hotel Dieu, Nantes Cedex 1, PAYS DE LA Loire, France
Centre Hospitalier Universitaire de Poitiers, Poitiers Cedex, Poitou-charentes, France
Centre Hospitalier Universitaire de Nice Hopital l'Archet, Nice Cedex 3, Provence Alpes COTE D'azur, France
Universitaetsklinikum Heidelberg, Mannheim, Baden-wuerttemberg, Germany
Universitatsklinikum Ulm, Ulm, Baden-wuerttemberg, Germany
Universitatsmedizin Rostock, Rostock, Mecklenburg-vorpommern, Germany
Uniklinik RWTH Aachen, Aachen, Nordrhein-westfalen, Germany
Universitaetsklinikum Essen, Essen, Nordrhein-westfalen, Germany
Universitatsklinikum Jena, Jena, Thuringen, Germany
Charite Universitatsmedizin Berlin, Berlin, , Germany
Universitatsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Azienda Ospedaliera San Gerardo di Monza, Monza, Monza E Brianza, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Pesaro E Urbino, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele, Catania, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo, Pescara, , Italy
Sapienza Universita Di Roma, Roma, , Italy
AOUI - Ospedale Policlinico "Giambattista Rossi" di Borgo Roma, Verona, , Italy
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw, Dolnoslaskie, Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, Lodzkie, Poland
Malopolskie Centrum Medyczne, Krakow, Malopolskie, Poland
Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Lisboa, , Portugal
Centro Hospitalar Sao Joao, Porto, , Portugal
Rostov State Medical University, Rostov-na-Donu, Rostov, Russian Federation
Chelyabinsk Regional Clinical Hospital, Chelyabinsk, , Russian Federation
Kemerovo Regional Clinical Hospital, Kemerovo, , Russian Federation
GBUZ Moscow Clinical Scientific Center DZM, Moscow, , Russian Federation
Russian Academy of Medical Science, Moscow, , Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology, Saint Petersburg, , Russian Federation
Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation, Saint Petersburg, , Russian Federation
Samara State Medical University, Samara, , Russian Federation
Saratov State Medical University, Saratov, , Russian Federation
Singapore General Hospital, Singapore, , Singapore
Hospital Regional Universitario Carlos Haya, Malaga, Andalucia, Spain
Hospital Universitario de Gran Canaria Doctor Nergrin, Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Akademiska Sjukhuset, Uppsala, , Sweden
University Hospital Zurich, Zurich, , Switzerland
National Taiwan University Hospital, Taipei, , Taiwan
Royal Liverpool University Hospital NHS Trust, Liverpool, England, United Kingdom
King's College Hospital NHS Foundation Trust, London, England, United Kingdom
Imperial College Healthcare NHS Trust, London, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Churchill Hospital, Oxford, England, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
Contact Details
Name: Study Director Clinical Science
Affiliation: Takeda
Role: STUDY_DIRECTOR
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