coiaward2010

OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]

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)

Indication and most important 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)

Additional criteria apply.

Short description of intervention

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.

Type of study

Therapy optimization trials

Current status

Recruiting

Study sponsor

Ariad Pharmaceuticals (acquired by Takeda)

Scientific lead / contact

Heinrich Farin, MD,

Principal investigator

See site contact information

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

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.


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


Belgium

Gent, 9000
UZ Gent (Site 756)
Principal Investigator: Prof. Dr. Lucien Noens

Leuven, 3000
UZ Leuven Campus Gasthuisberg (Site 700)
Principal Investigator: Prof. Dr. Gregor Verhoef


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

Santiago, Metropolitana, 7500922
Hospital del Salvador (Site 829)
Contact: Maria Gianna Capurro
Principal Investigator: Maria Soledad Undurraga Sutton, MD

Vina del Mar, Quinta Regin, 254-0364
Centro de Investigaciones Clínicas Viña del Mar (Site 828)
Contact: Gina Castagneto
Principal Investigator: Christine Rojas Hopkins, MD


China

Hong Kong
Queen Mary Hospital (Site 973)
Principal Investigator: Prof. Kwong Yok-Lam


Czech Republic
Olomouc, 77520
Fakultni nemocnice Olomoue (Site 515)
Principal Investigator: prof. Karel Indrak, MD, PhD

Praha 2, 128 20
The Institute of Hematology and Blood Transfusion (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.


Finland

Jyvaskyla, 70029 Kuopio
Central Finland Central Hospital
Hematological Unit (Site 684)
Principal Investigator: Marita Nurmi


France

Angers Cedex 9, 44093 CHU Angers
Service Maladies du Sang (Site 685)
Principal Investigator: Dr. Martine Gardembas

Bordeaux, 33076
Institut Bergonie, 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
Hopital Archet 1 (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

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

California
City of Hope
Duarte, California, 91010 (Site 009)
Principal Investigator: David S. Snyder, MD

Georgia
Atlanta, Georgia, 30322
Emory University Hospital (Site 058)
Principal Investigator: Vamsi Kota, MD

Indiana
Indianapolis, Indiana, 46237
Indiana Blood and Marrow Transplantation Clinic (Site 138)
Principal Investigator: Luke Akard, MD

Iowa
Iowa City, Iowa, 52242
University of Iowa Hospitals and Clinics (Site 050)
Principal Investigator: Usha Perepu, MD

Maryland
Baltimore, Maryland, 21201
University of Maryland, Greenbaum Cancer 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

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
Hospital of the University of Pennsylvania (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