Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials

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What is this study about?

This study focuses on evaluating a medication called tazemetostat, which is given as a film-coated tablet taken by mouth. The study aims to assess the long-term safety of this medication in patients who have previously been treated with tazemetostat in other clinical trials and have shown benefit from the treatment.

The study will monitor patients who continue taking tazemetostat either alone or in combination with other approved or experimental medications. During the study, researchers will track any side effects that may occur and how well patients tolerate the medication over an extended period. The medication will be provided according to each patient’s previous treatment plan.

Participants will be monitored for various health measures, including their blood cell counts, kidney function, and liver function. The study will also track how long patients survive while receiving the treatment. This is an open-label study, which means all participants will receive the active medication, and there is no use of a placebo.

1 Initial eligibility verification

You must be currently receiving or have previously received tazemetostat treatment with proven clinical benefit

Your life expectancy needs to be more than 3 months

Your blood tests must show adequate bone marrow, kidney, and liver function

2 Medical screening for women

If you are a woman who can become pregnant, you will need a negative pregnancy test

You must agree to use both a highly effective birth control method (such as implants, pills, or IUDs) and a barrier method (such as condoms) during treatment and for 6 months after the last dose

3 Medical screening for men

If you are male, you must either have had a vasectomy and use condoms, or you and your partner must use effective birth control during treatment and for 3 months after the last dose

4 Treatment administration

You will receive tazemetostat as film-coated tablets for oral use

The dosage will follow the same pattern as in your previous treatment program

The treatment will continue as long as you show clinical benefit

5 Monitoring period

Your health status will be regularly monitored to check for any side effects

The study team will track how long you take the medication

Your survival status will be monitored throughout the study period

6 Study duration

The study is planned to continue until September 2025

Your participation duration will depend on your individual response to treatment and any side effects you may experience

Who Can Join the Study?

Must be currently benefiting from treatment with tazemetostat (a medication used in the study)
Must be currently receiving tazemetostat either alone or in combination with other medications as part of a clinical trial
Must be willing and able to provide written informed consent and follow all study requirements
Must have a life expectancy of more than 3 months
Must have adequate:
– Blood cell counts
– Bone marrow function
– Blood clotting factors
– Kidney function
– Liver function
For female participants who can become pregnant:
– Must have a negative pregnancy test at study entry
– Must use both a highly effective birth control method (such as implants, injections, birth control pills, or IUDs) and a barrier method (such as condoms) during treatment and for 6 months after
Women who cannot become pregnant (due to menopause, hysterectomy, or removal of ovaries) do not need pregnancy testing
For male participants:
– Must have had a successful vasectomy and remain abstinent or use effective contraception
– Must use condoms throughout the study and for 3 months after stopping treatment
– Or their female partner must meet the above contraception requirements

Who Cannot Join the Study?

Patients who are not currently receiving tazemetostat treatment in a previous clinical study
Patients who have experienced severe side effects during previous treatment with tazemetostat
Patients who are unable to comply with the long-term safety monitoring requirements
Patients who have developed any medical condition that makes continued treatment unsafe
Patients who have withdrawn consent from their previous tazemetostat study
Patients who have missed scheduled doses or failed to follow study procedures in their previous trial
Patients who have developed progressive disease while on tazemetostat treatment
Patients who are participating in other clinical trials simultaneously
Patients who have developed any contraindications to tazemetostat treatment
Patients who cannot continue long-term follow-up visits as required by the study protocol

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Henri Becquerel	Rouen	France
Pratia S.A.	Skorzewo	Poland
Hopital Huriez	Lille	France
Iqlxtnnz Bsksavpk	Bordeaux	France
Awooahaxto Pjprnuwn Hicbxyst Dt Pzune	Paris	France
Nizibvsb Ipeuhhtj Ocsgprthy Imt Mpgqz Swdkiuahetoiiwyudkojnxyqtdgn Ieijrxjx Bttueyaz	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2016
Poland	Not recruiting	01.09.2016

Trial locations

Investigated drugs:

Tazemetostat

Tazemetostat is a medication that works by targeting specific enzymes in cancer cells. It belongs to a class of drugs called EZH2 inhibitors, which help control the growth of certain types of cancer cells. This medication is being studied for long-term safety in patients who have previously participated in other tazemetostat clinical trials.

Investigated diseases:

Based on the provided source data, there isn’t enough specific information about diseases to create disease descriptions. The trial data only mentions that subjects will receive tazemetostat treatment, but does not specify the medical conditions being treated. Without clear disease information from the source data, I cannot provide accurate disease descriptions in the requested format.

To create accurate disease descriptions, I would need specific disease names or conditions mentioned in the source data. The current data focuses on a medication trial’s objectives and endpoints rather than describing specific medical conditions.

Trial ID:

2023-510553-41-00

Protocol code:

EZH-501

NCT ID:

NCT02875548

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?