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.

Phase 2

Completed

• Conditions: Renal Cell Carcinoma; Patients Who Have/Have Had Melanoma and Other Tumors; Colorectal Neoplasms; Prostatic Neoplasms; Neoplasms; Melanoma
• Interventions: Drug: CP-675,206 (Tremelimumab)

• Registration Number: NCT00378482
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-20
• Study Start: 2007-03-05
• Results First Submitted: 2021-01-26
• Results First Submitted QC: 2021-05-05
• Results First Posted: 2021-05-28
• Primary Completion: 2023-10-27
• Study Completion: 2023-10-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CP-675,206 (Tremelimumab)	Drug: CP-675,206 (Tremelimumab)

Primary Outcome Measures

Name	Time	Method
Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.	Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Serious Adverse Events to Tremelimumab.	Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Survival	Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.	Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.
Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)	Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival	Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years.	Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first

Trial Locations

Locations (1)

Research Site; 🇬🇧 Newecastle Upon Tyne, United Kingdom