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

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ClinicalTrials.gov Identifier: NCT00431275
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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
Melanoma Drug: CP-675,206 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : June 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Pharmacokinetics: maximum plasma concentration of CP-675,206 [ Time Frame: 1 hour ]
  2. Pharmacokinetics: AUC, defined as the area under the concentration -time curve [ Time Frame: Time 0 to Day 85 ]

Secondary Outcome Measures :
  1. Human-anti-human antibodies [ Time Frame: 1 year ]
  2. Adverse events [ Time Frame: 1 year ]
  3. Safety laboratory tests [ Time Frame: 1 year ]
  4. Proportion of patients alive and free of disease at 1 year [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431275


Locations
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United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85260
United States, Colorado
Research Site
Aurora, Colorado, United States, 80010
United States, Florida
Research Site
Aventura, Florida, United States, 33180
Research Site
Miami Beach, Florida, United States, 33140
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, New York
Research Site
New York, New York, United States, 10016
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
Research Site
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00431275    
Other Study ID Numbers: A3671011
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Tremelimumab
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Ipilimumab
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action