Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
NCT ID: NCT02629692
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
122 participants
INTERVENTIONAL
2016-06-27
2026-08-31
Brief Summary
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Detailed Description
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Part B dose-escalation study is completed. Recruitment in dose expansion is completed.
Part C study in subjects with treatment-resistant/intolerant is ongoing for the enrolled subjects.
Conditions
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Study Design
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NA
SINGLE_GROUP
Part B: Multiple ascending dose safety and tolerability study in subjects with CML or Ph + ALL.
Part C: Efficacy and safety study in subjects with treatment-resistant CML
TREATMENT
NONE
Part A: 2 arms: Investigational agent arm and Placebo arm (Double-blind).
Study Groups
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Vodobatinib (K0706) capsules
Vodobatinib (K0706) capsules
Part A: Vodobatinib (K0706) capsules in single ascending doses.
Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.
Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily.
Interventions
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Vodobatinib (K0706) capsules
Part A: Vodobatinib (K0706) capsules in single ascending doses.
Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.
Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
Downey, California, United States
UCLA Hematologic Malignancy Program
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Board of Regents of the University System of Georgia
Augusta, Georgia, United States
Memorial Sloan Kettering Cancer Center - MAIN
New York, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Institut Paoli Calmettes
Marseille, Bouches-du-Rhône, France
Centre Léon Bérard
Lyon, Rhone, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, France
Debreceni Egyetem
Debrecen, , Hungary
Prince Aly Khan Hospital
Mumbai, Maharashtra, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
Sahyadri Specialty Hospital
Pune, Maharashtra, India
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, India
Tata Medical Centre
Kolkata, West Bengal, India
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola, Forli - Cesena, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, Milano, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale Sant'Eugenio
Roma, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, , Italy
Spitalul Clinic Colentina
Bucharest, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, , Romania
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Gyeonggi-do, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Gyeonggi-do, South Korea
Uijeongbu Eulji Medical Center, Eulji University
Gyeonggi-do, , South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hacettepe University Hospital
Altındağ, , Turkey (Türkiye)
Kayseri Erciyes University Hospital
Kayseri, , Turkey (Türkiye)
King's College Hospital
London, Greater London, United Kingdom
Hammersmith Hospital
London, Greater London, United Kingdom
Countries
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References
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Cortes JE, Kim DW, Saikia T, Khattry N, Rathnam K, Alvarado Y, Hannah G, Tantravahi SK, Apperley JF, Charbonnier A, Garcia-Gutierrez V, Lucchesi A, Dima D, Illes A, Popov VM, Abruzzese E, Nag A, Apte S, Badar T, Yao SL, Saxena U, Sreenivasan J, Inamdar S, Chimote G, Nicolini FE. Vodobatinib for patients with Philadelphia chromosome-positive chronic myeloid leukaemia resistant or intolerant to multiple lines of previous therapy: an open-label, multicentre, phase 1/2 trial. Lancet Haematol. 2025 Mar;12(3):e201-e213. doi: 10.1016/S2352-3026(24)00354-5. Epub 2025 Feb 7.
Other Identifiers
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CLR_15_03 V 12 Amendment 12
Identifier Type: -
Identifier Source: org_study_id
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