Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

Sun Pharma Advanced Research (SPARC)

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Healthy (For Part A)

Chronic Myeloid Leukemia (for Part B and C)

Treatments

Drug: Vodobatinib (K0706) capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT02629692

CLR_15_03 V 12 Amendment 12

Details and patient eligibility

About

Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

Full description

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 is ongoing for the enrolled subjects.

Enrollment

122 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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