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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357655
• Other study ID #: CA180-363
• Secondary ID: 2011-000083-10
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2011
• Last updated: December 6, 2016
• Start date: September 2011
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor.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The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• Dasatinib
Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response
• BMS-833923
Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response

Locations

Country	Name	City	State
Argentina	Local Institution	San Miguel De Tucuman	Tucuman
Belgium	Local Institution	Antwerpen
Belgium	Local Institution	Brugge
Canada	Local Institution	Edmonton	Alberta
Finland	Local Institution	Helsinki
France	Local Institution	Bordeaux
France	Local Institution	Le Chesnay
France	Local Institution	Lille
France	Local Institution	Nantes	Cedex
France	Local Institution	Paris Cedex 10
France	Local Institution	Strasbourg Cedex
France	Local Institution	Toulouse Cedex 09
Poland	Local Institution	Chorzow
Poland	Local Institution	Gdansk
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Wroc#aw
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Oviedo
Spain	Local Institution	Pamplona
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	Tennessee Oncology Pllc	Nashville	Tennessee
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Finland,  France,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare Major Molecular Response (MMR) rates for dasatinib alone versus dasatinib combined with SMO-antagonist in newly diagnosed Chronic Phase (CP) CML subjects (who did not achieve MMR within 1 year of treatment with dasatinib alone).		Within 18 months from start of treatment	No
Secondary	Complete molecular response at any time		Approximately 5 years	No
Secondary	Progression-free survival, measured by the time from start of treatment to progression or death		Approximately 5 years	No
Secondary	Event-free survival, measured by the time from start of treatment to progression, death or treatment discontinuation		Approximately 5 years	No
Secondary	Transformation-free survival measured by the time from start of treatment to criteria for accelerated or blast phase CML are met and death		Approximately 5 years	No
Secondary	Safety of combination, measured by incidence of Serious Adverse Events and Adverse Events, deaths, laboratory values, and results of Electrocardiogram (ECG) will be assessed		Approximately 5 years	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form