Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

TAZEMETOSTAT ROLLOVER STUDY (TRUST): AN OPEN-LABEL, ROLLOVER STUDY

This study, called TRUST, is for individuals who have previously participated in a clinical trial involving a cancer medication known as tazemetostat. It's an 'open-label' study, meaning both the patient and the doctors know they are receiving tazemetostat. The main goal is to continue giving the drug to these patients and carefully monitor their health. Researchers will be looking at any side effects patients experience and how well they can cope with the medication. They will also track how long patients continue to take the drug. This information is crucial for understanding the long-term safety and tolerability of tazemetostat as a cancer treatment. The study also aims to see how long patients live after starting tazemetostat.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Epizyme Inc.

Enrolment target

Start

22 May 2024

Subjects will receive tazemetostat as dictated in their antecedent study.

What is this study about?

This study, called TRUST, is designed for individuals who have already been taking part in another clinical trial for a cancer drug named tazemetostat. Think of it as a continuation study. Instead of finishing their treatment after the initial trial, eligible patients will be able to keep receiving tazemetostat.

The main purpose of this study is to gather more information about the long-term safety of tazemetostat. The researchers will be closely watching for any side effects, both expected and unexpected, that patients might experience. They'll also be assessing how well patients tolerate the drug over an extended period. This means they want to understand if the drug causes too many problems or if patients can generally continue taking it without severe difficulties.

Another important aspect of this study is to see how long patients continue to take the drug and, ultimately, to understand its effect on their lifespan. By extending the treatment and monitoring, the research team hopes to build a more complete picture of tazemetostat's overall impact as a cancer treatment.

Key takeaways

This study is for people already taking the cancer drug tazemetostat in a previous trial.
It aims to gather more information on the long-term safety and side effects of tazemetostat.
Participants will continue receiving tazemetostat and be closely monitored.
The study also looks at how long patients live while taking the drug.
You must be at least 18 years old to join.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must have already taken part in a previous clinical trial for the drug tazemetostat and meet the requirements set out in that earlier study. This means it's not a study for people who haven't tried tazemetostat before.

The study is open to both men and women. You must also be at least 18 years old to participate. There isn't an upper age limit mentioned, so older adults may also be eligible if they meet the other criteria.

Your study doctor will be able to confirm if you meet all the necessary conditions based on your previous participation and overall health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I already participated in a clinical trial for the drug tazemetostat?
Am I at least 18 years old?
Do I fit the specific health requirements from my original tazemetostat study?
Am I willing to attend regular check-ups and monitoring visits?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the drug tazemetostat, just as you did in your previous trial. The exact schedule for taking the drug will follow what was established in your initial study. You will have regular visits with the study team. During these visits, the doctors and nurses will closely monitor your health to check for any side effects. They will likely ask you questions about how you are feeling, perform physical examinations, and take blood samples. The overall length of your participation will depend on how you respond to the treatment and whether you continue to tolerate the drug well. The study aims to provide ongoing treatment and monitoring for as long as it is beneficial and safe for you.

Potential risks and benefits

The potential benefits of joining this study include continuing to receive tazemetostat treatment, which you were on in a previous trial, and potentially benefiting from its effects on your condition over a longer period. However, like all medications, tazemetostat can have side effects, and these could develop or change over time. The study team will monitor you closely for any adverse effects, which are a key focus of this research. You have the right to withdraw from the study at any time and for any reason, without it affecting your future medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Poland

Common questions

What is tazemetostat?

Tazemetostat is a specific type of cancer drug that you would have received in a previous clinical trial.

Why is this study called a 'rollover' study?

It's called a rollover study because it allows participants from an earlier trial to 'roll over' or continue receiving the treatment they were on for a longer period.

Will I know if I'm getting the active drug?

Yes, this is an 'open-label' study, which means both you and your doctors will know that you are receiving tazemetostat.

What kind of safety checks will be done?

The study team will regularly check for any side effects you might experience and monitor how well your body tolerates the drug over time.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, and this will not affect your usual medical care.