Detail of the clinical trial
Title of the trial | 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) opr Philadelphia Chromosome Positive Acute Lymhoblastic leukemia (Ph+ALL) |
---|---|
EudraCT number | 2016-001754-18 |
Protocol number | CLR_15_03 |
Sponsor | Sun Pharma Advanced Research Company Ltd., 17-B Mahal Industrial Estate, Mahakali Caves Road Andheri, Mumbai 400093, India |
Indications | Hemato-oncology |
Diagnosis | Chronic Myeloid Leukemia |
Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
Year of receiving the request to Institute (SÚKL) | 2017 |
Date of approval by Institute (SÚKL) | 10.5.2017 |
Date of approval by EC | 7.6.2017 |
Date of initiation CT in ČR | nezahájena |
Date of ending CT in ČR | 6. 6. 2019 |
Notice | |
Sites | Fakultní nemocnice Brno, Interní hematologická a onkologická klinika, Jihlavská 20, 625 00 Brno |