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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma
• Intervention / Treatment: Drug: CP-675,206

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80010
      • Research Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Research Site
    • Miami Beach, Florida, United States, 33140
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Commercial Formulation	Drug: CP-675,206; CP-675,206 15 mg/kg iv single dose on Day 1; Other Names: anti-CTLA4 human monoclonal antibody
EXPERIMENTAL: Current Formulation	Drug: CP-675,206; CP-675,206 15 mg/kg iv single dose on Day 1; Other Names: anti-CTLA4 human monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: February 2, 2007
• First Submitted That Met QC Criteria: February 2, 2007
• First Posted (ESTIMATE): February 5, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Tremelimumab; Ipilimumab
• Other Study ID Numbers: A3671011