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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

once-weekly dosing

Group Type EXPERIMENTAL

XL228

Intervention Type DRUG

1-hour IV infusion

2

twice-weekly dosing

Group Type EXPERIMENTAL

XL228

Intervention Type DRUG

1-hour IV infusion

Interventions

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XL228

1-hour IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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:

1. CML

* Chronic phase (CP)
* Accelerated phase (AP)
* Blast phase (BP) OR
2. Ph+ ALL
2. 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
3. The subject is at least 18 years old.
4. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
5. The subject has adequate organ function.
6. The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
7. Sexually active subjects must use an accepted method of contraception during the course of the study.
8. Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Exclusion Criteria

1. The subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of XL228.
2. The subject has received an investigational agent or radiotherapy within 28 days of the first dose of XL228.
3. 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.
4. 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.
5. The subject has not recovered to CTCAE v3.0 Grade ≤1 from adverse events (AEs) due to investigational drugs or other medications.
6. The subject has known allergy or hypersensitivity to any component of the investigational drug product.
7. 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.
8. The subject is pregnant or breastfeeding.
9. The subject is known to be positive for the human immunodeficiency virus (HIV).
10. The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No