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

Phase 2TerminatedNCT01357655

Bristol-Myers Squibb70 enrolled

Overview

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.

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 Design: Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor.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 Research Hypothesis : The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor.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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

DasatinibDRUG

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

BMS-833923DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

John Theurer Cancer Center

Hackensack, New Jersey, United States

Tennessee Oncology Pllc

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Number of Participants With Major Molecular Response

Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.

Time frame: Baseline up to 12 months

Secondary Outcomes

Complete Molecular Response at Any Time

Time frame: Baseline to End of study (approximately 48 months)

Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death

Time frame: Baseline to End of study (approximately 48 months)

Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation

Time frame: Baseline to End of study (approximately 48 months)

Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death

Time frame: Baseline to End of study (approximately 48 months)

Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.

Data from ClinicalTrials.gov

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