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Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SU011248
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Metastatic colorectal cancer Failed selected cancer therapies in the past. Exclusion Criteria: Prior treatment with tyrosine kinase inhibitors or VEGF inhibitors other than bevacizumab.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Anti-tumor efficacy

    Secondary Outcome Measures

    Tumor control survival safety

    Full Information

    First Posted
    February 13, 2004
    Last Updated
    January 9, 2007
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00077987
    Brief Title
    Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.
    Official Title
    A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And A Fluoropyrimidine, With And Without Bevacizumab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer who have failed selected previous treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    84 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SU011248
    Primary Outcome Measure Information:
    Title
    Anti-tumor efficacy
    Secondary Outcome Measure Information:
    Title
    Tumor control survival safety

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Metastatic colorectal cancer Failed selected cancer therapies in the past. Exclusion Criteria: Prior treatment with tyrosine kinase inhibitors or VEGF inhibitors other than bevacizumab.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.

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