A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Melanoma; Neoplasms; Prostatic Neoplasms; Patients Who Have/Have Had Melanoma and Other Tumors; Colorectal Neoplasms; Renal Cell Carcinoma

Treatments: Drug: CP-675,206 (Tremelimumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00378482

2008-000989-23 (EudraCT Number)

D4881C00024 (A3671024) (Other Identifier)

D4881C00024

Details and patient eligibility

About

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.

Enrollment: 37 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject must have already received tremelimumab in another protocol
• Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
• Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

1

Experimental group

Description:

Drug: CP-675,206 (Tremelimumab)

Treatment:

Drug: CP-675,206 (Tremelimumab)