Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory / Intolerant CML Failing ≥3 Prior CML Therapies

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, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Part C).

Exclusion Criteria

• Presence of T315I (PART C)
• 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

Part A ( for Healthy volunteers) of the study is completed

Part B dose-escalation study is completed. Recruitment in dose-expansion is ongoing in India

and Korea

Part C study in subjects with treatment-refractory/intolerant is enrolling globally.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Sun Pharma Advanced Research Company Limited

• Primary ID CLR_15_03 V 12 Amendment 12
• 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, CLR_15_03 V 11 amendment 11
• Clinicaltrials.gov ID NCT02629692