Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
1 other identifier
interventional
85
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2006
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 2, 2007
CompletedFirst Posted
Study publicly available on registry
February 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedJune 6, 2012
June 1, 2012
1.7 years
February 2, 2007
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics: maximum plasma concentration of CP-675,206
1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
Time 0 to Day 85
Secondary Outcomes (4)
Human-anti-human antibodies
1 year
Adverse events
1 year
Safety laboratory tests
1 year
Proportion of patients alive and free of disease at 1 year
1 year
Study Arms (2)
Commercial Formulation
EXPERIMENTALCommercial Formulation
Current Formulation
EXPERIMENTALCurrent Formulation
Interventions
CP-675,206 15 mg/kg iv single dose on Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of chronic inflammatory or autoimmune disease
- History of inflammatory bowel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Scottsdale, Arizona, 85260, United States
Research Site
Aurora, Colorado, 80010, United States
Research Site
Aventura, Florida, 33180, United States
Research Site
Miami Beach, Florida, 33140, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
New York, New York, 10016, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2007
First Posted
February 5, 2007
Study Start
June 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 6, 2012
Record last verified: 2012-06