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Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00413686
Collaborator
(none)
42
Enrollment
2
Locations
1
Arm
41
Duration (Months)
21
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Malignancies
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

AZD7762 monotherapy followed by AZD7762 + gemcitabine

Drug: AZD7762
intravenous infusion

Drug: Gemcitabine
weekly intravenous infusion
Other Names:
  • Gemzar®
  • Gemcitabine HCL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine [Assessed after each course of treatment]

    Secondary Outcome Measures

    1. To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762. [Assessed after each course of treatment]

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective

    • ECOG performance status of 0 or 1

    • Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.

    Exclusion Criteria:

    • Inadequate bone marrow reserve, inadequate liver function or impaired renal function

    • Any troponin elevation (above normal range)

    • Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction [MI])

    • Any prior anthracycline treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Baltimore Maryland United States
    2 Research Site Detroit Michigan United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Peter Langmuir, M.D., AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00413686
    Other Study ID Numbers:
    • D1040C00002
    First Posted:
    Dec 20, 2006
    Last Update Posted:
    Dec 6, 2010
    Last Verified:
    Dec 1, 2010
    Keywords provided by , ,
    Mixed solid tumors
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Dec 6, 2010