PH II DASATINIB COMBO w/ SMO INHIBITOR (BMS-833923)

• Conditions: newly diagnosed Ph+ CP CML; MedDRA version: 18.1Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864; MedDRA version: 18.1Level: PTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000083-10-FI
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-27
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Eligibility criteria are no longer applicable as all subjects are enrolled.

1. Subjects >= 18 years of age who have signed informed consent
2. Philadelphia positive chronic myeloid leukemia (CML) in chronic phase
3. Previously untreated
4. Performance status 0 - 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Eligibility criteria are no longer applicable as all subjects are enrolled.

1. Known Abl-kinase T315I or T315A mutation
2. Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition
3. Prior chemotherapy
4. Patients who are pregnant or breastfeeding or likely to become pregnant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified