Safety, Tolerability, Pharmacokinetics and Activity of K0706

Phase 1 / 2 study to determine safety, tolerability, pharmacokinetics and activity of K0706

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, or Ph+ ALL

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

Part A ( for Healthy volunteers) of the study is completed Part B (for CML subject ) of the study is ongoing. (Recruitment for Part B initiated in April 2017) Part C of study in subjects with CML and Ph+ ALL is on-going. (Open for Recruitment )

Lead Organization
Sun Pharma Advanced Research Company Limited

Primary ID CLR_15_03 V 11 amendment 11
Secondary IDs NCI-2017-00230, CLR_15_03, CLR_15_03 V09 amendment 09, CLR_15_03 V04 amendment 04, CLR_15_03 V08 amendment 08, CLR_15_03 V 10 amendment 10
Clinicaltrials.gov ID NCT02629692