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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Melanoma

Treatments: Drug: CP-675,206

Study type: Interventional

Funder types: Industry

Identifiers

NCT00431275

A3671011

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Commercial Formulation

Experimental group

Description:

Commercial Formulation

Treatment:

Drug: CP-675,206

Drug: CP-675,206

Current Formulation

Experimental group

Description:

Current Formulation

Treatment:

Drug: CP-675,206

Drug: CP-675,206