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Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT00937664
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
19.1
Duration (Months)
1.3
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 AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies
Study Start Date :
Jul 1, 2009
Anticipated Primary Completion Date :
Feb 1, 2011
Anticipated Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: AZD7762 + gemcitabine

AZD7762 administered alone and in combination with gemcitabine

Drug: AZD7762
solution, intravenous, weekly

Drug: gemcitabine
intravenous, weekly
Other Names:
  • Gemzar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram [Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2]

    Secondary Outcome Measures

    1. Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine [According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1]

    2. Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST) [Every 2-3 cycles]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.

    • Must be suitable for treatment with gemcitabine

    • Relatively good overall health other than cancer

    Exclusion Criteria:

    • Poor bone marrow function (not producing enough blood cells).

    • Poor liver or kidney function.

    • Serious heart conditions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Minami-ku Fukuoka Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Peter Langmuir, MD, AstraZeneca
    • Principal Investigator: Takashi Seto, MD, PhD, National Hospital Organization Kyushu Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00937664
    Other Study ID Numbers:
    • D1040C00008
    First Posted:
    Jul 13, 2009
    Last Update Posted:
    Feb 7, 2011
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    Phase I
    cancer
    solid tumors
    advanced solid malignancies
    dose escalation
    combination treatment
    CHK inhibitor
    Japanese
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Feb 7, 2011