Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia

Stopped early · Phase 1

Conditions studied: Chronic Myeloid Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

In brief

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.

Key facts

Study ID

NCT00464113

Run by

Exelixis

People needed

49

Starts

2007-05-01

Expected to finish

2011-04-01

Last updated by the study team

2015-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA School of Medicine — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• Georgetown University Medical Center, Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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