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 States, United Kingdom37 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 range

18 Years – 130 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 130 Years

Sex

ALL

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.