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

Stopped early · Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT01357655

Run by

Bristol-Myers Squibb

People needed

70

Starts

2011-09-01

Expected to finish

2016-01-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• John Theurer Cancer Center — Hackensack, New Jersey, United States
• Tennessee Oncology Pllc — Nashville, Tennessee, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Local Institution — San Miguel de Tucumán, Tucumán Province, Argentina
• Local Institution — Antwerp, Belgium
• Local Institution — Bruges, Belgium
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Helsinki, Finland
• Local Institution — Nantes, Cedex, France
• Local Institution — Bordeaux, France
• Local Institution — Le Chesnay, France
• Local Institution — Lille, France
• Local Institution — Paris, France
• Local Institution — Strasbourg, France
• Local Institution — Toulouse, France
• Local Institution — Chorzów, Poland
• Local Institution — Gdansk, Poland
• Local Institution — Krakow, Poland
• Local Institution — Lodz, Poland
• Local Institution — Wroc#aw, Poland
• Local Institution — Madrid, Spain
• Local Institution — Madrid, Spain
• Local Institution — Oviedo, Spain
• Local Institution — Pamplona, Spain

Full record on ClinicalTrials.gov

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