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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00827138
First received: January 21, 2009
Last updated: May 30, 2013
Last verified: May 2013
  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)

Resource links provided by NLM:


Further study details as provided by Deciphera Pharmaceuticals LLC:

Primary Outcome Measures:
  • Assess the safety and tolerability of the drug [ Time Frame: Completion of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the Pharmacokinetic profile and preliminary evidence of clinical response [ Time Frame: Completion of the study ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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 Names:
  • DCC-2036
  • rebastinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible:

  • Ph+ CML in Chronic Phase with T315I mutation
  • 18 years or older
  • The subject has an ECOG performance status of ≤ 2.
  • Adequate organ function as indicated by the following laboratory assessments performed within 14 days prior to the first dose of study drug Hepatic: Serum bilirubin ≤1.5 times upper limit (X ULN) of normal unless due to leukemic involvement or Gilbert's syndrome; aspartate aminotransferase or alanine aminotransferase ≤ 2.5 X ULN; alkaline phosphatase ≤ 2.5 X ULN Renal: Serum creatinine ≤ 1.5 X ULN or 24 hour creatinine clearance ≥ 50 mL/min
  • Female subjects of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin pregnancy test within 14 days prior to the start of study drug
  • Sexually active subjects who are fertile must agree to use an effective barrier method of contraception while on therapy and for 30 days following discontinuation of study drug. Non-fertile subjects or those not sexually active are also eligible.
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion Criteria: Subjects presenting with any of the following will not qualify for entry into the study:

  • Subject has received chemotherapy or a TKI ≤ 7 days, investigational agent ≤ 14 days, or radiotherapy ≤ 28 days prior to the start of study drug or has not recovered from the acute toxicities associated with any prior treatments including approved therapies, investigational agents, and prior stem cell or bone marrow transplant. The following exceptions apply: i) Hydroxyurea is permitted at any time prior to study enrollment; ii) Glucocorticoids (natural or synthetic) are allowed up to 48 hours prior to the start of the study drug (with the exception of steroids for pre-medication and topical/nasal steroid use which are allowed at any time)
  • The subject has AP or BP-CML
  • Received immunosuppressive therapy ≤ 28 days prior to the first dose of study drug
  • NY Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure
  • Myocardial infarction within 3 months of the start of study drug
  • Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant
  • Any other severe concurrent disease and/or uncontrolled medical conditions, which in the judgment of the investigator, could predispose subjects to unacceptable safety risks or compromise compliance with the protocol
  • Human immunodeficiency virus positive
  • If female, the subject is pregnant or lactating
  • Allergic or hypersensitive to any component of the investigational drug product
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827138

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
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
Investigators
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

Additional Information:
No publications provided by Deciphera Pharmaceuticals LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: May 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014