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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00431275
First received: February 2, 2007
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Melanoma
Drug: CP-675,206
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetics: maximum plasma concentration of CP-675,206 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Pharmacokinetics: AUC, defined as the area under the concentration -time curve [ Time Frame: Time 0 to Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Human-anti-human antibodies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety laboratory tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients alive and free of disease at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431275

Locations
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00431275     History of Changes
Other Study ID Numbers: A3671011
Study First Received: February 2, 2007
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014