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

 Chronic myeloid leukemia (CML) / Posted 1 year ago

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

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.

  • Inclusion Criteria :
    • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: No
    • 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
  • Study start date : April 25, 2017
  • Study end date : August 2026
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Jane Apperley (Hammersmith Hospital)
Contact details

Hammersmith Hospital, LondonLondon,England,W12 0HS

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