Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias



Status:Archived
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:March 2009
End Date:September 2011

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A Multicenter Phase 1 Clinical and Pharmacokinetic Study of DCC-2036 in Subjects With Philadelphia Positive Chromosome Leukemias


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 myelogenous leukemia and
Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia. 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.

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.



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Boston, Massachusetts 02111
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1400 South Orange Avenue
Orlando, Florida 32806
407-648-3800
M. D. Anderson Cancer Center Welcome to UF Health Cancer Center at Orlando Health. For...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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