Chronic Lymphocytic Leukemia Clinical Trial
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior CML Therapies
Summary
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
Full Description
Part A ( for Healthy volunteers) of the study is completed
Part B dose-escalation study is completed. Recruitment in dose-expansion is ongoing in India and Korea
Part C study in subjects with treatment-refractory/intolerant is enrolling globally.
Eligibility Criteria
Inclusion Criteria:
Willing and able to give written, and dated, informed consent
Male or female aged ≥ 18 years
Willing and able to comply with the scheduled visits
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Part C).
Exclusion Criteria:
Presence of T315I (PART C)
Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
Inability to undergo venipuncture and/or tolerate venous access
Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
Known or suspected history of significant drug abuse as judged by the Investigator
Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant
Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ
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There are 73 Locations for this study
Downey California, 90241, United States More Info
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Los Angeles California, 90024, United States More Info
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Los Angeles California, 90033, United States More Info
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Augusta Georgia, 30912, United States More Info
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Indianapolis Indiana, 46237, United States More Info
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Hackensack New Jersey, 07601, United States More Info
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New York New York, 10065, United States
Valhalla New York, 10595, United States
Greenville North Carolina, 27858, United States More Info
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Dallas Texas, 75226, United States More Info
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Houston Texas, 77030, United States More Info
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Salt Lake City Utah, 84112, United States More Info
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Marseille Cedex 9 Bouches-du-Rhône, 13273, France More Info
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Bordeaux cedex Gironde, 33076, France
Limoges cedex Haute Vienne, 87042, France More Info
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Rennes cedex 9 Ille Et Vilaine, 35033, France More Info
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Nantes cedex 1 Loire Atlantique, 44000, France More Info
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Angers Maine Et Loire, 49033, France More Info
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Vandœuvre-lès-Nancy Meurthe Et Moselle, 54511, France More Info
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Lille cedex Nord, 59037, France More Info
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Salouel Somme, 80480, France
Poitiers Vienne, 86021, France
Nyiregyhaza , 4400, Hungary More Info
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Mumbai Maharashtra, 40001, India
Mumbai Maharashtra, 40001, India
Pune Maharashtra, 41100, India
Madurai Tamilnadu, 62510, India
Kolkata West Bengal, 70002, India
Kolkata West Bengal, 70015, India
Meldola Forli - Cesena, 47014, Italy More Info
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Monza Milano, 20900, Italy More Info
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Catania , 95124, Italy More Info
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Milano , 20122, Italy More Info
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Milano , 20162, Italy More Info
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Roma , 00161, Italy More Info
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Seoul Gyeonggi-do, 06591, Korea, Republic of
Seoul Gyeonggi-do, 6591, Korea, Republic of
Gyeonggi-do , 11759, Korea, Republic of More Info
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Cluj-Napoca , 40012, Romania More Info
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Craiova , 20014, Romania More Info
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Târgu Mureș , 54013, Romania More Info
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Singapore , 16985, Singapore
Badalona Barcelona, 08916, Spain More Info
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Girona , 17007, Spain More Info
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Madrid , 28034, Spain More Info
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Málaga , 29010, Spain More Info
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Sevilla , 41009, Spain More Info
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Sevilla , 41013, Spain More Info
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London Greater London, SE5 9, United Kingdom More Info
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