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OpenTrials
Completed

NCT Number: NCT00431275

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-675,206

Drug

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

Other names: anti-CTLA4 human monoclonal antibody

Primary outcomes

  1. Pharmacokinetics: maximum plasma concentration of CP-675,206

    Time frame: 1 hour

  2. Pharmacokinetics: AUC, defined as the area under the concentration -time curve

    Time frame: Time 0 to Day 85

Secondary outcomes

  1. Human-anti-human antibodies

    Time frame: 1 year

  2. Adverse events

    Time frame: 1 year

  3. Safety laboratory tests

    Time frame: 1 year

  4. Proportion of patients alive and free of disease at 1 year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 5, 2007
Registry last updated
Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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