MDX010-28: Long-term Data Collection for Subjects in MDX-010 Studies

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00928031
Collaborator
(none)
160
11
22
14.5
0.7

Study Details

Study Description

Brief Summary

The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
    Study Start Date :
    Jun 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2009
    Actual Study Completion Date :
    Apr 1, 2009

    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:
      1. Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-15.

      2. Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.

      3. For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Arizona Cancer Center Tuscon Arizona United States 85724
      2 Pacific Shores Medical Group Long Beach California United States 90813
      3 The Angeles Clinic and Research Institute Los Angeles California United States 90025
      4 USC Norris Cancer Center Los Angeles California United States 90033
      5 University of Miami Sylvester Cancer Center Miami Florida United States 33136
      6 St. Francis Research Foundation Beech Grove Indiana United States 46107
      7 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
      8 NYU Cancer Institute New York New York United States 10016
      9 Carolinas Cancer Care Charlotte North Carolina United States 28211
      10 Providence Portland Medical Center Portland Oregon United States 97213
      11 Huntsman Cancer Institute Salt Lake City Utah United States 84112

      Sponsors and Collaborators

      • Bristol-Myers Squibb

      Investigators

      • Principal Investigator: Walter Urba, MD PhD, Providence Health & Services

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00928031
      Other Study ID Numbers:
      • MDX010-28
      First Posted:
      Jun 25, 2009
      Last Update Posted:
      Apr 26, 2010
      Last Verified:
      Apr 1, 2010
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Apr 26, 2010