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Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
Sponsor: Sun Pharma Advanced Research Company Limited
Summary
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
Official title: A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2016-06-27
Completion Date
2026-08
Last Updated
2024-07-31
Healthy Volunteers
No
Interventions
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.
Locations (38)
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