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

Leukemia Clinical Trial

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).

Status Completed

Clinical Trial 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.

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Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor.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The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor.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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

• NCT number: NCT01357655
• Study type: Interventional
• Source: Bristol-Myers Squibb
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Completion date: January 2016