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

  • STATUS
    Recruiting
  • End date
    Aug 18, 2026
  • participants needed
    303
  • sponsor
    Sun Pharma Advanced Research Company Limited
Updated on 18 May 2022
ponatinib

Summary

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

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.

Details
Condition Healthy (For Part A), Chronic Myeloid Leukemia (for Part B and C)
Treatment Placebo, K0706, K0706 capsules, Vodobatinib (K0706) capsules
Clinical Study IdentifierNCT02629692
SponsorSun Pharma Advanced Research Company Limited
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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