Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866736
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group

Tracking Information
First Submitted Date  ICMJE March 18, 2009
First Posted Date  ICMJE March 20, 2009
Last Update Posted Date September 15, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects [ Time Frame: at 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2009)
  • safety after treatment with dasatinib [ Time Frame: 2 year ]
  • rate of Complete Cytogenetic Response(CCyR) [ Time Frame: 2 year ]
  • rate of Complete Hematologic Response (CHR) [ Time Frame: 2 year ]
  • efficacy on patients with BCR-ABL point mutations [ Time Frame: 2 year ]
  • progression free survival [ Time Frame: 2 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Official Title  ICMJE A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Brief Summary The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Myeloid Leukemia
Intervention  ICMJE Drug: dasatinib
100mg QD
Other Name: BMS-354825
Study Arms  ICMJE Experimental: dasatinib
Intervention: Drug: dasatinib
Publications * Inokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2015)
65
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2009)
60
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed Written Informed Consent
  • Subjects with chronic phase chronic myeloid leukemia (CML)
  • Subjects resistant/intolerant to imatinib
  • Subjects presenting:

    1. ECOG performance status (PS) score 0-2
    2. Adequate hepatic function
    3. Adequate renal function
    4. Adequate lung function

Exclusion Criteria:

  • Concurrent malignancy other than CML
  • Women who are pregnant or breastfeeding
  • Concurrent pleural effusion
  • Uncontrolled or significant cardiovascular disease
  • A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
  • Prior therapy with dasatinib
  • Subjects with T315I and/or F317L BCR-ABL point mutations
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00866736
Other Study ID Numbers  ICMJE KCSG-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Study Sponsor  ICMJE Kanto CML Study Group
Collaborators  ICMJE Epidemiological and Clinical Research Information Network
Investigators  ICMJE
Principal Investigator: Hisashi Sakamaki, MD.PhD Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
PRS Account Kanto CML Study Group
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP