Dasatinib Combo With SMO Inhibitor (BMS-833923)
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | January 2011 |
End Date: | June 2015 |
Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
Email: | Clinical.Trials@bms.com |
Dasatinib (BMS-354825) Combined With SMO Inhibitor (BMS-833923; XL139) in CML With Resistance or Suboptimal Response to a Prior TKI
The purpose of the study is to determine the safety, and tolerability of the combination of
BMS-833923 plus dasatinib in subjects with chronic phase CML.
Key Inclusion Criteria:
- Subjects ≥ 18 years of age
- Chronic myeloid leukemia (CML) in chronic or advanced phase (including Ph+ALL) with
progression/failure during or suboptimal response to imatinib, nilotinib or dasatinib
(see protocol for details)
- Performance Status 0-1 with resolution of toxicity from prior therapy
Key Exclusion Criteria:
- Known Abl-kinase T315I or T315A mutation
- Laboratory abnormalities:
- Uncorrected serum calcium or phosphate below institutional LLN
- Amylase or lipase Grade ≥1
- Blood count values Grade ≥3
- Serious or uncontrolled medical disorder (including infection or cardiovascular
disease) or dementia or other serious psychiatric condition
- Women who are pregnant or breastfeeding or WOCBP who are unwilling or unable to use
an acceptable method to avoid pregnancy during the entire study period
- Must be ≥6 months after stem cell transplantation
- Sexually active fertile men (with partners that are WOCBP) not using effective birth
control for duration of study and for at least 3 months following combination
treatment.
We found this trial at
4
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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