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Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00431275
Collaborator
(none)
85
Enrollment
8
Locations
2
Arms
20
Duration (Months)
10.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Commercial Formulation

Commercial Formulation

Drug: CP-675,206
CP-675,206 15 mg/kg iv single dose on Day 1
Other Names:
  • anti-CTLA4 human monoclonal antibody

    		•
    Experimental: Current Formulation

    Current Formulation

    Drug: CP-675,206
    CP-675,206 15 mg/kg iv single dose on Day 1

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics: maximum plasma concentration of CP-675,206 [1 hour]

    2. Pharmacokinetics: AUC, defined as the area under the concentration -time curve [Time 0 to Day 85]

    Secondary Outcome Measures

    1. Human-anti-human antibodies [1 year]

    2. Adverse events [1 year]

    3. Safety laboratory tests [1 year]

    4. Proportion of patients alive and free of disease at 1 year [1 year]

    Eligibility Criteria

    Criteria

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

    • Stage III or Stage IV melanoma

    • No evidence of disease following resection of melanoma lesions

    • Recovered from all prior surgical or adjuvant treatment-related toxicities

    Exclusion Criteria:

    • History of chronic inflammatory or autoimmune disease

    • History of inflammatory bowel disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Scottsdale Arizona United States 85260
    2 Research Site Aurora Colorado United States 80010
    3 Research Site Aventura Florida United States 33180
    4 Research Site Miami Beach Florida United States 33140
    5 Research Site Atlanta Georgia United States 30322
    6 Research Site New York New York United States 10016
    7 Research Site Philadelphia Pennsylvania United States 19104
    8 Research Site Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00431275
    Other Study ID Numbers:
    • A3671011
    First Posted:
    Feb 5, 2007
    Last Update Posted:
    Jun 6, 2012
    Last Verified:
    Jun 1, 2012
    Additional relevant MeSH terms:
    Melanoma
    Tremelimumab
    Ipilimumab

    Study Results

    No Results Posted as of Jun 6, 2012