Status:
COMPLETED
Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Age ≥18 years
- Diagnosis of chronic myeloid leukemia (CML) and cytogenetic positive for the Philadelphia chromosome (Ph+), documented Ph+ cells on bone marrow assessment (BMA) ≤6 weeks prior to treatment
- Either chronic-phase CML, with \<15% blasts in peripheral blood and bone marrow, or advanced-phase CML, including Ph+ acute lymphoblastic leukemia (ALL) (\> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
- Resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known T315I/A Abl-kinase mutation.
- Key Exclusion Criteria
- Known Abl-kinase T315I or T315A mutation
- CCyR at baseline
- Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- Uncontrolled or significant cardiovascular disease
- Grade 3 or higher peripheral blood counts
- Serum calcium or phosphate below the lower limit of normal
- Baseline hypomagnesemia and amylase or lipase at least Grade 1 or higher
- Reduced renal function, defined as serum creatinine level \>3\*upper limit of normal
- Prior therapies for CML or Ph+ ALL permitted, with the following restriction:
- Therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
- 6 months or longer after stem cell transplantation
- 28 days or longer after any investigational agent
- 7 days or longer after any standard chemotherapy agent
- Concomitant use of medications with a known risk of causing Torsades de Pointes
- Concomitant use of strong inhibitors of the CYP3A4 isoenzyme
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01218477
Start Date
January 1 2011
End Date
April 1 2013
Last Update
June 17 2016
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University Of California Medical Center
San Francisco, California, United States, 94143
2
Sidney Kimmel Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
3
Ut M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
4
Local Institution
Hamilton, Ontario, Canada, L8N 3Z5