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)
Description
Brief Summary
Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706
Detailed Description
Part A ( for Healthy volunteers) of the study is completed
Part B (for CML subject ) of the study is ongoing only in India, other countries completed.
(Recruitment for Part B initiated in April 2017)
Part C of study in subjects with CML is on-going in all mentioned countries except India.
(Open for Recruitment )
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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