Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation)
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
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.