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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-01-31

Brief Summary

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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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Detailed Description

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Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor.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The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor.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

Conditions

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Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Dasatinib

Group Type ACTIVE_COMPARATOR

Dasatinib

Intervention Type DRUG

Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response

Arm2: Dasatinib + BMS-833923

Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response

BMS-833923

Intervention Type DRUG

Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response

Interventions

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Dasatinib

Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response

Intervention Type DRUG

BMS-833923

Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response

Intervention Type DRUG

Other Intervention Names

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Sprycel®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No