Clincosm LogoSign in Get a demo

Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT00460460
Collaborator
(none)
75
Enrollment
3
Locations
5
Duration (Months)
25
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN
Study Start Date :
Mar 1, 2007
Actual Study Completion Date :
Aug 1, 2007

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 AML, a certain type of ALL, NHL and MM

    • certain types of cancer of the lymph nodes

    • certain types of leukemias (blood cancers)

    • disease has or will fail with other treatments

    • relatively good overall health other than your cancer

    Exclusion Criteria:

    • poor bone marrow function (not producing enough blood cells)

    • serious heart conditions

    • poor liver or kidney function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research site Buffalo New York United States
    2 Research Site New York New York United States
    3 Research Site Toronto Ontario Canada

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Judith Ochs, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00460460
    Other Study ID Numbers:
    • D2782C00002
    First Posted:
    Apr 16, 2007
    Last Update Posted:
    Jan 25, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    Phase I
    cancer
    lymphoma
    leukemia
    myeloma
    AML
    ALL
    NHL
    MM
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Jan 25, 2011