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

Phase 1

• Conditions: newly diagnosed Ph+ CP CML; MedDRA version: 14.0Level: LLTClassification code 10034877Term: Philadelphia chromosome positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-01
• Study Completion: 2016-01-25
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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. Women who are pregnant or breastfeeding or WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Complete molecular response at any time <br>Progression-free survival <br>Event-free survival <br>Transformation-free survival <br>Safety of combination;Primary end point(s): To compare MMR rates for dasatinib alone versus dasatinib combined with SMO-antagonist in newly diagnosed CP CML subjects (who did not achieve MMR within 1 year of treatment with dasatinib alone);Timepoint(s) of evaluation of this end point: Within 18 months from start of treatment;Main Objective: The purpose of the study is to compare response rates in newly<br>diagnosed CP CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Complete molecular response at any time <br>Progression-free survival<br>Event-free survival <br>Transformation-free survival <br>Safety of combination;Timepoint(s) of evaluation of this end point: Approximately 5 years