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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CP-675,206
CP-675,206
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Commercial Formulation

Current Formulation

Arm Description

Commercial Formulation

Current Formulation

Outcomes

Primary Outcome Measures

Pharmacokinetics: maximum plasma concentration of CP-675,206
Pharmacokinetics: AUC, defined as the area under the concentration -time curve

Secondary Outcome Measures

Human-anti-human antibodies
Adverse events
Safety laboratory tests
Proportion of patients alive and free of disease at 1 year

Full Information

First Posted
February 2, 2007
Last Updated
June 5, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00431275
Brief Title
Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
Official Title
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Commercial Formulation
Arm Type
Experimental
Arm Description
Commercial Formulation
Arm Title
Current Formulation
Arm Type
Experimental
Arm Description
Current Formulation
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Other Intervention Name(s)
anti-CTLA4 human monoclonal antibody
Intervention Description
CP-675,206 15 mg/kg iv single dose on Day 1
Intervention Type
Drug
Intervention Name(s)
CP-675,206
Intervention Description
CP-675,206 15 mg/kg iv single dose on Day 1
Primary Outcome Measure Information:
Title
Pharmacokinetics: maximum plasma concentration of CP-675,206
Time Frame
1 hour
Title
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
Time Frame
Time 0 to Day 85
Secondary Outcome Measure Information:
Title
Human-anti-human antibodies
Time Frame
1 year
Title
Adverse events
Time Frame
1 year
Title
Safety laboratory tests
Time Frame
1 year
Title
Proportion of patients alive and free of disease at 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Research Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Research Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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