Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sun Pharma Advanced Research Company Limited
Part A ( for Healthy volunteers) of the study is completed.
Part B dose-escalation study is completed. Recruitment in dose expansion is completed.
Part C study in subjects with treatment-resistant/intolerant CML is also completed.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Healthy males aged 18 to 55 years
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 (Subjects with Ph+ ALL are not included).
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
You may not be if
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: HIV, hepatitis B surface antigen, or hepatitis C virus
Known or suspected history of significant drug abuse as judged by the Investigator
Presence of T315I
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
Clareo Health | Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
