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

Trial Status: Active

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

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

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Christine Duran
Phone: 323-865-0371
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Bruck Habtemariam
Phone: 310-794-0242
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Christine Duran
Phone: 323-865-0371

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Bobbie Ann Frye
Phone: 317-274-2992

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Michael John Mauro
Phone: 212-639-3107

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW

South Carolina

Charleston
Medical University of South Carolina
Status: IN_REVIEW

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: WITHDRAWN

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 V04 amendment 04, CLR_15_03 V08 amendment 08, CLR_15_03 V09 amendment 09, CLR_15_03 V 10 amendment 10, CLR_15_03 V 11 amendment 11
  • Clinicaltrials.gov ID NCT02629692