OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]
Type of study
Therapy optimization trials
Current status
Active, not recruiting
Study title
OPTIC = Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia (CML) to Characterize the Efficacy and Safety of a Range of Doses
Scientific title
OPTIC (Optimising Ponatinib Treatment In CML) – 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 (EudraCT 2014-001617-12, NCT02467270, AP24534-14-203)
What is the purpose of the study
To characterize the efficacy of ponatinib administered in three starting doses (45mg, 30mg, and 15mg daily) in patients with CP-CML who are resistant to at least two TKIs, as measured by major cytogenetic response (MCyR) by 12 months.
Key inclusion criteria
This study includes patients who:
– have chronic myeloid leukemia in chronic phase (CP-CML) and are resistant to at least two prior tyrosine kinase inhibitors (TKI)
– are at least 18 years old, have an Eastern Co-Operative Group (ECOG) status of 0-2, have given written informed consent and comply with scheduled visits and study procedures
– have fully recovered from the acute effects of prior cancer therapy before initiation of study drug
– have adequate kidney, liver and pancreas function
– have a negative pregnancy test, use a highly effective form of contraception from randomization through at least 4 months after the end of treatment (for female and male patients who are fertile)
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Ariad Pharmaceuticals (acquired by Takeda)
Scientific lead / contact
Takeda Study Registration Call Center 866-835-2233
globaloncologymedinfo@takeda.com
Principal investigator
See site contact information
Study centers / principal investigators
Argentina
Buenos Aires, Argentina, 1221
Hospital Ramos Mejia (Site 826)
Contact: Claudio Merlo
Principal Investigator: Elena B Moiraghi, MD
Caba, Buenos Aires, C1114AAN
Fundaleu (Site 825)
Contact: Miguel Frau
Principal Investigator: Carolina Pavlovsky, M.D.
La Plata, Buenos Aires, B1900AXI
Hospital Italiano La Plata
Australia
New South Wales
St. Leonards, New South Wales, 2065
Royal North Shore Hospital (Site 941)
Contact: Vicki Katsioulas
Principal Investigator: Christopher K Arthur, MD
Adelaide, 5000
Royal Adelaide Hospital, Haematology Clinical Trials (Site 951)
Principal Investigator: Professor Timothy Peter Hughes
Canada
Ontario
Toronto, Ontario, M5G2M9
Princess Margaret Cancer Centre (Site 083)
Principal Investigator: Jeffrey Howard Lipton
Quebec
Montreal, Quebec, H3T IE2
Jewish General Hospital (Site 129)
Contact: Marie Pascale Guay
Principal Investigator: Sarit Assouline, MD
Saskatchewan
Regina, Saskatchewan, S4T 1A5
Pasqua Hospital (Site 227)
Principal Investigator: Haji Chalchal, MD
Chile
Providencia, Santiago, 7500922
Hospital del Salvador (Site 829)
Contact: Maria Gianna Capurro
Principal Investigator: Maria Soledad Undurraga Sutton, MD
Vina del Mar, Valparaiso, 254-0364
Centro de Investigaciones Clínicas Viña del Mar (Site 828)
Contact: Gina Castagneto
Principal Investigator: Christine Rojas Hopkins, MD
Czech Republic
Olomouc, 77520
Fakultni nemocnice Olomoue (Site 515)
Principal Investigator: prof. Karel Indrak, MD, PhD
Praha 2, 128 20
Ustav Hematologie a Krevni Transfuze Praha (UHKT) (Site 516)
Contact: Jana Vedrova
Principal Investigator: Hana Klamova
Denmark
Aarhus C, 8000
Haematologisk Afdeling, Arahus Universitehospital (Site 683)
Principal Investigator: Prof. Jesper Stentoft, M.D.
France
Angers Cedex 9, 44993 CHU Angers
Service Maladies du Sang (Site 685)
Principal Investigator: Dr. Martine Gardembas
Bordeaux, 33076
Centre de Lutte Contre le Cancer – Institut Bergonie (Site 772)
Principal Investigator: Dr. Gabriel Etienne
Lille, Nord, 59037 CEDEX Hopital Claude Huriez CHRU (Site 952)
Contact: Sylvie Brice
Principal Investigator: Valerie Coiteux, MD
Nantes Cedex, 44093
CHU Hotel-Dieu, Service d’Hematologie Clinique (Site 521)
Principal Investigator: Dr. Viviane Dubruille
Nice Cedex 3, 06202
Centre Hospitalier Universitaire de Nice Hopital l’Archet (Site 509)
Contact: Marie-Christine Rigualt
Principal Investigator: Laurence Legros
Poitiers, B.p. 577, 86021
CHRU de Poitiers, Department of Oncology-Hematology and Cell Therapy (Site 954)
Principal Investigator: Prof. Francois Guilhot
Toulouse Cedex 9, Midi-pyrenees, 31059
Institut Universitaire du Cancer de Toulouse Oncopole
Vandoeuvre-les-Nancy Cedex, 54511
University Teaching Hospital – CHU Brabois (Site 953)
Principal Investigator: Dr. Agnes-Paule Guerci-Bresler
Germany
Aachen, 52074
Universitätsklinikum Aachen, AOR (Site 513)
Contact: Sabrina Holst
Principal Investigator: Martina Crysandt, MD
Berlin, 13353
Universitätsmedizin Berlin – Charité (CVK) (Site 701)
Contact: Peggy Grill
Principal Investigator: Philipp Le Coutre, MD
Essen, 45147
Essen University Hospital (Site 686)
Contact: Ilona Vester
Principal Investigator: Jürgen Novotny, MD
Freiburg, 79106
University Hospital Freiburg (Site 527)
Contact: Joana Meisenzahl
Principal Investigator: Nikolas von Bubnoff, MD
Hamburg, 20246
University Cancer Center Hamburg (Site 524)
Hubertus Wald Tumorzentrum
Contact: Juliane Granzow
Principal Investigator: Philippe Schafhausen, MD
Jena, 07740
Universitätsklinikum Jena (Site 946)
Contact: Denise Mathes
Principal Investigator: Andreas Hochhaus, PhD, MD
Mannheim, 68169
University of Heidelberg (Site 947)
Contact: Regina Pleil-Losch
Principal Investigator: Susanne Saussele, MD
Ulm, 89081
University Hospital of Ulm (Site 694)
Contact: Beate Böltau
Principal Investigator: Frank Stegelmann, MD
Italy
Catania, 95124
University Hospital Policlinico (Site 530)
Contact: Giovanna Pappalardo
Principal Investigator: Francesco Di Raimondo, MD
Genova, 16132
V.O. Clinica Ematologica (Site 528)
Contact: Maria Attilia Grassi
Principal Investigator: Marco Gobbi
Monza, 20900
ASST San Gerardo Hospital (Site 355)
Contact: Dario Cerri
Principal Investigator: Carlo Gambacorti-Passerini, MD
Pesaro, Pesaro e Urbino, 61122
A.O. Ospedali Riuniti Marche Nord (Site 689)
Contact: Maurizio Nardelli
Principal Investigator: Giuseppe Visani, MD
Pescara, 65124
Pescara Civil Hospital (Site 688)
Contact: Giuseppina Di Florio
Principal Investigator: Paolo Di Bartolomeo, MD
Roma, 00161
University La Spienza (Site 511)
Contact: Enrica Arduini
Principal Investigator: Giuliana Alimena
Verona, 37134
Ospedale Borgo Roma – Verona (Site 687)
Contact: Giorgia Barbiero
Principal Investigator: Massimiliano Bonifacio, MD
Japan
Fukuoka, 812-0054
Kyushu University Hospital (Site 423)
Contact: Tomoko Nishida
Principal Investigator: Katsuto Takenaka, MD
Kurashiki, Okayama, 710-8602
Kurashiki Central Hospital (Site 427)
Contact: Takako Ikegami
Principal Investigator: Yasunori Ueda, MD
Kyoto, 602-8566
University Hospital Kyoto
Prefectural University of Medicine (Site 419)
Contact: Shigeru Tsukamoto
Principal Investigator: Masafumi Taniwaki
Minatoga, Tokyo, 105-8471
The Jikei University Hospital (Site 428)
Contact: Dai Harada
Principal Investigator: Shingo Yano
Nagoya, Aichi, 464-8681
Aichi Cancer Center Hospital (Site 414)
Contact: Seiji Ohshima
Principal Investigator: Kazuhito Yamamoto
Nishinomiya, Hyogo, 663-8501
Hospital of Hyogo College of Medicine (Site 429)
Contact: Hiroshi Suzuki
Principal Investigator: Masaya Okada, MD
Okayama, 700-8558
Okayama University Hospital (Site 418)
Contact: Toshimitsu Konuma
Principal Investigator: Yoshinobu Maeda, MD
Osaka, 545-0051
Osaka City University Hospital (Site 413)
Contact: Miyuki Amakawa
Principal Investigator: Hirohisa Nakamae
Osaka-Sayama, Osaka, 589-8511
Kindai University Hospital (Site 422)
Contact: Tomoko Kawase
Principal Investigator: Itaru Matsumura
Saga, 849-8501
Saga University Hospital (Site 420)
Contact: Sachiko Takemori
Principal Investigator: Shinya Kimura
Saitama, 350-8550
Saitama Medical Center
Saitama Medical University (Site 416)
Contact: Mashu Morimoto
Principal Investigator: Masahiro Kizaki, MD
Sapporo, Hokkaido, 060-8648
Hokkaido University Hospital (Site 415)
Contact: Norihiro Sakakibara
Principal Investigator: Takanori Teshima
Tokyo, 104-0045
National Cancer Center Hospital (Site 421)
Contact: Yuka Saito
Principal Investigator: Yukio Kobayashi, MD
Tokyo, 108-8639
The Institute of Medical Science
The University of Tokyo (Site 417)
Contact: Minako Kono
Principal Investigator: Arinobu Tojo, MD
Tokyo, 160-0023
Tokyo Medical University Hospital (Site 430)
Contact: Akira Mae
Principal Investigator: Tetsuzo Tauchi
Korea, Republic of
Seoul, Korea, Republic of, 137-701
The Catholic University of Korea Seoul
St. Mary’s Hospital (Site 938)
Principal Investigator: Dong-Wook Kim, M.D., PhD
Norway
Bergen, 5021
Bergens Universitetssjukhus (Site 690)
Contact: Ingeborg Tennebekk Nessa
Principal Investigator: Bjorn T Gjertsen, MD, PhD
Poland
Krakow, 30-510
Malopolskie Medical Center (Site 546)
Contact: Marta Kowalowka
Principal Investigator: Tomasz Sacha, MD
Łódź, Poland, 93-510
Klinika Hematologii Uniwersytetu Medycznego w Łodzi (Site 550)
Contact: Magdalena Przybysz
Principal Investigator: Tadeusz Robak, MD
Warszawa, Poland, 02-776
Klinika Hematologii (Site 691)
Contact: Urszula Szustkiewicz
Principal Investigator: Krzysztof Warzocha, MD
Wrocław, Poland, 50-369
Independent Public Clinical Hospital No. 1 in Wroclaw (Site 547)
Contact: Mariusz Grajcar
Principal Investigator: Ewa Medras, MD
Portugal
Lisboa, 1099-023
Instituto Portugues de Oncologia de Lisboa (Site 545)
Contact: Ana Inacio
Principal Investigator: Antonio M Almeida, MD/PhD
Porto, 4200-319
Centro Hospitalar de S. João (Site 559)
Contact: Raquel Ribeiro
Principal Investigator: Manuel S Simões
Russian Federation
Kemerovo, 650066
Kemerovo Regional Clinical Hospital (Site 455)
Contact: Ludmila Chervova
Principal Investigator: Marina Kosinova, MD
Moscow, 111123
Moscow Clinical Scientific Center (Site 453)
Contact: Galina Dudina
Principal Investigator: Mikhail Y Byakhov, MD
Moscow, 125167
Haematological Scientific Center (Site 452)
Contact: Nemchenko Irina, MD
Principal Investigator: Anna Turkina, MD
Saint-Petersburg, 197341
Federal State Budgetary Institution V. A. Almazov
Federal North-West Medical (Site 454)
Contact: Irina Shakhomirova
Principal Investigator: Elza Lomaia, MD
Singapore
Outram Road, Singapore, 169608
Singapore General Hospital (Site 939)
Principal Investigator: Dr. Charles Chuah Thuan Heng
Spain
Barcelona, Cataluna, 08036
Hospital Clinic, Service de Hematologia (Site 963)
Principal Investigator: Francisco Cervantes
Las Palmas de Gran Canaria, Islas Canarias, 35010
Hospital Universitario de Gran Canaria Dr Negrin (Site 692)
Contact: Mireya A Lopez
Principal Investigator: Maria Teresa Gomez Casares, MD
Madrid, 28006
Hospital Universitario de la Princesa
Hematology Service, 2a Planta (Site 555)
Principal Investigator: Juan Luis Steegmann Olmedillas
Madrid, 28034
Hospital Universitario Ramon y Cajal (Site 538)
Principal Investigator: Valentin Garcia Gutierrez
Hospital Clinico Universitario de Valencia (Site 964)
Malaga, Andalucia, 29010
Hospital Regional Universitario Carlos Haya (Site 698)
Principal Investigator: Antonio Jimenez Velasco
Valencia, Spain, 46010
Hospital Clinico Universitario de Valencia (Site 964)
Principal Investigator: Juan Carlos Hernandez Boluda
Valencia, Spain, 46026
Hospital Universitari i Politecnic La Fe (Site 666)
Contact: Maria Tordera
Principal Investigator: Jaime Sanz Caballer
Sweden
Uppsala, SE-751 85
University Hospital Uppsala (Site 945)
Contact: Aime Mukenyuzi
Principal Investigator: Ulla Olsson-Stromberg, M.D., Ph.D.
Switzerland
Zurich, 8091
University Hospital Zurich (Site 562)
Contact: Isabell Pieper-Scholz
Principal Investigator: Stefan Balabanov, MD
Taiwan
Taipei, 100
National Taiwan University Hospital (Site 979)
Principal Investigator: Jih-Luh Tang, M.D., PhD.
United Kingdom
Glasgow, G12 0YN
NHS Greater Glasgow & Clyde
The Beatson West of Scotland Cancer Centre (Site 797)
Principal Investigator: Professor Tessa Holyoake
Liverpool, L7 8XP
The Royal Liverpool University Hospital (Site 969)
Principal Investigator: Professor Richard Clark
London, SE5 9RS
King’s College Hospital NHS Foundation Trust (Site 693)
Principal Investigator: Dr. Hugues de Lavallade
London, W120NN
Hammersmith Hospital (Site 967)
Contact: Regina Storch
Principal Investigator: Jane F Apperley, MD
Newcastle Upon Tyne, NE7 7DN
The New Castle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital (Site 970)
Contact: Mai Kay Jones
Principal Investigator: Wendy Osborne
Nottingham, NG5 1PB
The Centre for Clinical Haematology
Notthingham University Hospitals NHS Trust (Site 968)
ontact: Maria Scott
Principal Investigator: Jennifer Byrne
United States
Georgia
Atlanta, Georgia, 30322
Emory University Hospital Winship Cancer Institute (Site 058)
Principal Investigator: Vamsi Kota, MD
Indiana
Indianapolis, Indiana, 46237
Indiana Blood and Marrow Transplantation Clinic (Site 138)
Principal Investigator: Luke Akard, MD
Maryland
Baltimore, Maryland, 21201
University of Maryland Medical Center (Site 040)
Principal Investigator: Maria Baer, MD
Michigan
Ann Arbor, Michigan, 48109
University of Michigan Health System (Site 011)
Principal Investigator: Moshe Talpaz, MD
Detroit, Michigan, 48201
Karmanos Cancer Institute (Site 034)
Principal Investigator: Charles Schiffer, MD
Minnesota
Minneapolis, Minnesota, 55455
University of Minnesota Medical School
Nebraska
Omaha, Nebraska, 68198-7680
University of Nebraska Medical Center (Site 235)
Principal Investigator: Lori Maness-Harris, MD
New Jersey
Hackensack, New Jersey, 07601
Hackensack University Medical Center (Site 128)
Principal Investigator: James McCloskey II
New York
New York, New York, 10065
Memorial Sloan Kettering Cancer Center (Site 078)
Contact: Gerald O’Neill
Principal Investigator: Michael Mauro, MD
New York, New York, 10065
Weill Medical College of Cornell University and New York Presbyterian Hospital (Site 006)
Contact: Rachael Alettie
Principal Investigator: Ellen Ritchie, MD
North Carolina
Durham, North Carolina, 27710
Duke University Medical Center (Site 003)
Contact: Cheryl M Maxey
Principal Investigator: Joseph Moore, MD
Ohio
Cleveland, Ohio, 44195
Cleveland Clinic Foundation (Site 004)
Principal Investigator: Dr. Sudipto Mukherjee
Oregon
Portland, Oregon, 97239
Oregon Health & Science University (Site 048)
Contact: Jeanne Liming
Principal Investigator: Michael Heinrich
Pennsylvania
Philadelphia, Pennsylvania, 19104
Abramson Cancer Center (Site 013)
Principal Investigator: Selena Luger, MD
Texas
Houston, Texas, 77030
MD Anderson Cancer Center (Site 005)
Principal Investigator: Jorge E. Cortes, MD
Utah
Salt Lake City, Utah, 84112
Huntsman Cancer Institute (Site 043)
Principal Investigator: Michael Deiningeri, MD