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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDasatinib and BMS-833923

The study team can explain what participation involves.

Who it may be forLeukemia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 14, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: Dasatinib; Drug: BMS-833923

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

John Theurer Cancer CenterHackensack, New Jersey
Tennessee Oncology PllcNashville, Tennessee
Huntsman Cancer InstituteSalt Lake City, Utah
Local InstitutionSan Miguel de Tucumán, Tucumán Province
Local InstitutionAntwerp
Local InstitutionBruges
Local InstitutionEdmonton, Alberta
Local InstitutionHelsinki
Local InstitutionNantes, Cedex
Local InstitutionBordeaux
Local InstitutionLe Chesnay
Local InstitutionLille

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 14, 2017. Always confirm current availability with the study team.

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