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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Commercial Formulation

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

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

Current Formulation

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

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

Interventions

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CP-675,206

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

Intervention Type DRUG

CP-675,206

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

Intervention Type DRUG

Other Intervention Names

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anti-CTLA4 human monoclonal antibody

Eligibility Criteria

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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