CompletedPhase 2

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.

United States37 participantsStarted 2007-03-05

Plain-language summary

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

Who can participate

Age range18 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety Endpoints: Serious Adverse Events to Tremelimumab.

Timeframe: 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: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.

Timeframe: 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.

Timeframe: 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)

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT00378482

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-27

Results submitted2021-01-26

View on ClinicalTrials.gov More Colorectal Neoplasms trials

Who can participate

Age range18 Years – 130 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety Endpoints: Serious Adverse Events to Tremelimumab.

Timeframe: 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: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.

Timeframe: 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.

Timeframe: 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)

Timeframe: 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

Timeframe: 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.