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| Sponsor: | Deciphera Pharmaceuticals LLC |
|---|---|
| Information provided by (Responsible Party): | Deciphera Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT00827138 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia |
Drug: DCC-2036 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Phase 1 Clinical and Pharmacokinetic Study of DCC-2036 in Subjects With Leukemias (Ph+CML With T315I Mutation Only) |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DCC-2036
This is a single arm study
|
Drug: DCC-2036
150 mg BID tablets, continuous dosing of 28 day cycles
Other Name: DCC-2036
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible:
Exclusion Criteria: Subjects presenting with any of the following will not qualify for entry into the study:
Contacts and Locations| United States, California | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| The University of Kansas Cancer Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Maryland | |
| Sidney Kimmel Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Tufts Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
| Principal Investigator: | Hedy P Smith, MD | Tufts Medical Center |
| Principal Investigator: | Moshe Talpaz, MD | Univ. of Michigan Comprehensive Cancer Center |
| Principal Investigator: | Kapil Bhalla, MD | University of Kansas Cancer Center |
| Principal Investigator: | Richard A Larson, MD | University of Chicago |
| Principal Investigator: | H.Jean Khoury, MD | Emory University |
| Principal Investigator: | B. Douglas Smith, MD | Sidney Kimmel Cancer Center at Johns Hopkins |
| Principal Investigator: | Ehab Atallah, MD | Medical College of Wisconsin |
| Principal Investigator: | David Snyder, M.D. | Beckman Research Institute |
| Principal Investigator: | Javier Pinilla-Ibarz, MD,PhD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Responsible Party: | Deciphera Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT00827138 History of Changes |
| Other Study ID Numbers: | Protocol 2036-01 |
| Study First Received: | January 21, 2009 |
| Last Updated: | April 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |