Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation)
Completed · Phase 1
Conditions studied: Chronic Myeloid Leukemia
In brief
Rationale: DCC-2036 is a potent broad spectrum inhibitor of BCR-ABL kinase. Inhibition of BCR-ABL has been validated for effective treatment of chronic myeloid leukemia (CML). The emergence of mutant forms of BCR-ABL which resist inhibition by imatinib, dasatinib, and nilotinib is associated with loss of efficacy in treatment of the disease. DCC-2036 is a potent inhibitor of resistant mutants of BCR-ABL including the T315I mutation, and would therefore be expected to effectively treat patients who fail to respond to other BCR-ABL inhibitors. DCC-2036 also inhibits FLT3-ITD, TIE2, KDR, LYN and TRKA kinases. Purpose: to assess the safety and tolerability in patients after continuous administration of DCC-2036 and to determine recommended doses for the conduct of a Phase 2 efficacy trial.
Key facts
- Study ID
- NCT00827138
- Run by
- Deciphera Pharmaceuticals, LLC
- People needed
- 57
- Starts
- 2009-03-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2014-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- University of Chicago — Chicago, Illinois, United States
- The University of Kansas Cancer Center — Kansas City, Kansas, United States
- Sidney Kimmel Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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