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Study Safety and Preliminary Efficacy of DCC-2036 in Patients With Leukemias (Ph+ CML With T315I Mutation)

NCT00827138 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-07-18

No results posted yet for this study

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.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

DCC-2036

150 mg BID tablets, continuous dosing of 28 day cycles

Sponsors & Collaborators

  • Deciphera Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Jorge Cortes, MD · M.D. Anderson Cancer Center

  • Hedy P Smith, MD · Tufts Medical Center

  • Moshe Talpaz, MD · Univ. of Michigan Comprehensive Cancer Center

  • Kapil Bhalla, MD · University of Kansas

  • Richard A Larson, MD · University of Chicago

  • H.Jean Khoury, MD · Emory University

  • B. Douglas Smith, MD · Sidney Kimmel Cancer Center at Johns Hopkins

  • Ehab Atallah, MD · Medical College of Wisconsin

  • David Snyder, M.D. · City of Hope Medical Center

  • Javier Pinilla-Ibarz, MD,PhD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827138 on ClinicalTrials.gov