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Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

Sponsor
Exelixis (Industry)
Overall Status
Terminated
CT.gov ID
NCT00234481
Collaborator
(none)
3
Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of different doses of XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

    • Prior treatment with at least 2 systemic chemotherapy regimens for CLL

    • Life expectancy of >3 months

    • Adequate liver and kidney function

    • Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL

    • Willing to use accepted method of contraception during the course of the study

    • Negative pregnancy test (females)

    • Written informed consent

    Exclusion Criteria:

    • Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy)

    • Investigational drug within 30 days of the start of treatment

    • Uncontrolled intercurrent illness such as infection or cardiovascular disease

    • Pregnant or breastfeeding women

    • Subjects known to be HIV positive

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope National Cancer Center Duarte California United States 91010
    2 UCSD Moores Cancer Center San Diego California United States 92093
    3 UT MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Exelixis

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00234481
    Other Study ID Numbers:
    • XL844-001
    First Posted:
    Oct 7, 2005
    Last Update Posted:
    Jun 4, 2008
    Last Verified:
    Jun 1, 2008
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Jun 4, 2008