Status:
TERMINATED
Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia
Lead Sponsor:
Exelixis
Conditions:
Chronic Myeloid Leukemia
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.
Eligibility Criteria
Inclusion
- The subject has a confirmed pathologic diagnosis as evidenced by the presence of the BCR-Abl translocation \[t(9;22)\] by fluorescence in situ hybridization (FISH), cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the following:
- CML
- Chronic phase (CP)
- Accelerated phase (AP)
- Blast phase (BP) OR
- Ph+ ALL
- The subject has one of the following:
- Known T315I Abl mutation
- Known resistance to or intolerance of imatinib and dasatinib
- At least one prior anti-leukemia therapy, including, but not limited to, interferon, imatinib, or dasatinib
- The subject is at least 18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- The subject has adequate organ function.
- The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
- Sexually active subjects must use an accepted method of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
Exclusion
- The subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of XL228.
- The subject has received an investigational agent or radiotherapy within 28 days of the first dose of XL228.
- The subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease \[GVHD\]) within 28 days prior to the first dose of XL228.
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from toxicities related to peripheral stem cell or bone marrow transplant.
- The subject has not recovered to CTCAE v3.0 Grade ≤1 from adverse events (AEs) due to investigational drugs or other medications.
- The subject has known allergy or hypersensitivity to any component of the investigational drug product.
- The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00464113
Start Date
May 1 2007
End Date
April 1 2011
Last Update
August 21 2015
Active Locations (6)
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1
UCLA School of Medicine
Los Angeles, California, United States, 90095-1678
2
University of California San Francisco
San Francisco, California, United States, 94143-1270
3
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
4
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612