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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00464113
First received: April 18, 2007
Last updated: April 4, 2011
Last verified: April 2011

April 18, 2007
April 4, 2011
May 2007
June 2011   (final data collection date for primary outcome measure)
Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
Safety, tolerability, and maximum tolerated dose of weekly 1-hour intravenous (IV) infusion of XL228
Complete list of historical versions of study NCT00464113 on ClinicalTrials.gov Archive Site
  • Evaluate plasma pharmacokinetics and estimate renal elimination of once-weekly and twice-weekly 1-hour IV infusion of XL228 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • Exploratory Outcomes: Evaluate hematologic and cytogenetic response and pharmacodynamic correlates of XL228 activity [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
  • Evaluate plasma pharmacokinetics and estimate renal elimination of a single 1-hour IV infusion of XL228
  • Exploratory Outcomes: Evaluate hematologic and cytogenetic response and pharmacodynamic correlates of XL228 activity in plasma after repeated weekly administration of XL228
Not Provided
Not Provided
 
Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia (Ph+ ALL)

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Myeloid Leukemia
  • Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Drug: XL228
1-hour IV infusion
  • Experimental: 1
    once-weekly dosing
    Intervention: Drug: XL228
  • Experimental: 2
    twice-weekly dosing
    Intervention: Drug: XL228
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00464113
XL228-001
Yes
Paul Woodard, MD/Director, Clinical Research, Exelixis, Inc.
Exelixis
Not Provided
Not Provided
Exelixis
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP