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Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01357655
First received: May 18, 2011
Last updated: March 28, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.


Condition Intervention Phase
Leukemia
 Drug: Dasatinib
Drug: BMS-833923
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
Drug Information available for: Dasatinib
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare Major Molecular Response (MMR) rates for dasatinib alone versus dasatinib combined with SMO-antagonist in newly diagnosed Chronic Phase (CP) CML subjects (who did not achieve MMR within 1 year of treatment with dasatinib alone). [ Time Frame: Within 18 months from start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete molecular response at any time [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival, measured by the time from start of treatment to progression or death [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Event-free survival, measured by the time from start of treatment to progression, death or treatment discontinuation [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Transformation-free survival measured by the time from start of treatment to criteria for accelerated or blast phase CML are met and death [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Safety of combination, measured by incidence of Serious Adverse Events and Adverse Events, deaths, laboratory values, and results of Electrocardiogram (ECG) will be assessed [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 271
Study Start Date: September 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Dasatinib Drug: Dasatinib
Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response
Other Name: Sprycel®
Experimental: Arm2: Dasatinib + BMS-833923
Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response
 Drug: Dasatinib
Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response
Other Name: Sprycel®
Drug: BMS-833923
Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response

Detailed Description:

  1. Design:

    Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor. Subjects currently enrolled in the trial will continue to receive dasatinib alone at a starting dose of 100 mg QD for:

    1. a maximum of 5 years after entry into the study
    2. until progression by Investigators determination/judgment
    3. intolerance to Dasatinib
    4. the study is terminated due to safety concerns or
    5. other administrative reasons as communicated by the sponsor
  2. Research Hypothesis :

The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor. The objective of the altered design of this study is to describe the safety profile and tolerability of dasatinib

  Eligibility

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

Inclusion Criteria:

  • Subjects ≥ 18 years of age who have signed informed consent
  • Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase
  • Previously untreated chronic phase CML, except for Anagrelide or Hydroxyurea.
  • Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2

Exclusion Criteria:

  • Known Abl-kinase T315I or T315A mutation
  • Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
  • Prior chemotherapy.
  • Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357655

  Show 31 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01357655     History of Changes
Other Study ID Numbers: CA180-363, 2011-000083-10
Study First Received: May 18, 2011
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Myelogenous
Chronic
BCR-ABL Positive

Additional relevant MeSH terms:
Leukemia
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Translocation, Genetic
Chromosome Aberrations
 Pathologic Processes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013