Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
Phase 1
Completed
- Conditions
- Melanoma
- Interventions
- Drug: CP-675,206
- Registration Number
- NCT00431275
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
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
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Exclusion Criteria
- History of chronic inflammatory or autoimmune disease
- History of inflammatory bowel disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Commercial Formulation CP-675,206 Commercial Formulation Current Formulation CP-675,206 Current Formulation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Pittsburgh, Pennsylvania, United States