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).
18 Years
N/A
Both
Leukemia
Trial Information
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).
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Study Design and Duration as current described are no longer applicable since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The research hypothesis and primary objective of this study as originally designed are no
longer applicable as subjects enrolment has been terminated due to administrative reasons by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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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).
Outcome Time Frame:
Within 18 months from start of treatment
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA180-363
NCT ID:
NCT01357655
Start Date:
September 2011
Completion Date:
May 2017
Related Keywords:
- Leukemia
- Myelogenous
- Chronic
- BCR-ABL Positive
- Leukemia
- Philadelphia Chromosome
Name | Location |
|---|---|
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75235-8897 |
| Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
| The University Of Texas - M.D. Anderson Cancer Center | Houston, Texas 77030 |
| John Theurer Cancer Center | Hackensack, New Jersey 07601 |
| Oncology Hematology Care, Incorporated | Cincinnati, Ohio 45248 |
