Clinical trial NCT01357655: Phase 2 Dasatinib Combo With Smoothened (SMO) Antagonist (BMS-833923)
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia
Keywords: Myelogenous
Chronic
BCR-ABL Positive
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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   Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor.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The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor.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 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.

Primary outcomes:
measure: Number of Participants With Major Molecular Response
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Complete Molecular Response at Any Time
timeFrame: Baseline to End of study (approximately 48 months)
measure: Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death
timeFrame: Baseline to End of study (approximately 48 months)
measure: Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation
timeFrame: Baseline to End of study (approximately 48 months)
measure: Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death
timeFrame: Baseline to End of study (approximately 48 months)
measure: Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death
timeFrame: From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Nashville
country: United States
facility: Tennessee Oncology Pllc
state: Tennessee
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Antwerpen
country: Belgium
facility: Local Institution
city: Brugge
country: Belgium
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Helsinki
country: Finland
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
state: Cedex
city: Bordeaux
country: France
facility: Local Institution
city: Le Chesnay
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Toulouse Cedex 09
country: France
facility: Local Institution
city: Chorzow
country: Poland
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Wroc#aw
country: Poland
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Oviedo
country: Spain
facility: Local Institution
city: Pamplona
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: