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

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib

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.