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NCT00431275 Clinical Trial

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

Melanoma Clinical Trial

Official title:
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00431275
Other study ID # A3671011
Secondary ID
Status Completed
Phase Phase 1
First received February 2, 2007
Last updated June 5, 2012
Start date June 2006
Est. completion date February 2008

Study information
Verified date June 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Research Site Atlanta Georgia
United States Research Site Aurora Colorado
United States Research Site Aventura Florida
United States Research Site Miami Beach Florida
United States Research Site New York New York
United States Research Site Philadelphia Pennsylvania
United States Research Site Pittsburgh Pennsylvania
United States Research Site Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics: maximum plasma concentration of CP-675,206 1 hour No
Primary Pharmacokinetics: AUC, defined as the area under the concentration -time curve Time 0 to Day 85 No
Secondary Human-anti-human antibodies 1 year No
Secondary Adverse events 1 year No
Secondary Safety laboratory tests 1 year No
Secondary Proportion of patients alive and free of disease at 1 year 1 year No
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