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

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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
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Baltimore, MD
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1500 E Medical Center Dr
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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Ann Arbor, MI
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1515 Holcombe Blvd
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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Houston, TX
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Los Angeles, California 90095
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Los Angeles, CA
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