In short
Currently, there is 1 ongoing clinical trial for patients with recurrent malignant mesothelioma. This trial focuses on the long-term safety of tazemetostat, a medication that has shown benefit in previous studies. The trial is being conducted in France and Poland and is open to patients who have previously participated in tazemetostat clinical trials and continue to benefit from the treatment.
Clinical trial locations
- France
- Poland
Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials
This clinical trial is designed to evaluate the long-term safety of tazemetostat in patients who have already been treated with this medication in other clinical trials and have experienced clinical benefit. The study monitors patients who continue taking tazemetostat either alone or in combination with other approved or experimental medications.
Main inclusion criteria:
- You must currently be benefiting from treatment with tazemetostat
- You should have a life expectancy of more than 3 months
- Your blood tests must show adequate bone marrow, kidney, and liver function
- Women who can become pregnant must have a negative pregnancy test and agree to use highly effective birth control (such as implants, pills, or IUDs) plus a barrier method (such as condoms) during treatment and for 6 months afterward
- Men must either have had a vasectomy and use condoms, or they and their partner must use effective birth control during treatment and for 3 months after the last dose
Main exclusion criteria:
- Patients who are not currently receiving tazemetostat treatment in a previous clinical study
- Patients who experienced severe side effects during previous treatment with tazemetostat
- Patients who have developed progressive disease while on tazemetostat treatment
- Patients who cannot comply with long-term safety monitoring requirements
- Patients who are participating in other clinical trials at the same time
- Patients who have developed any medical condition that makes continued treatment unsafe
Focus and goal of the trial: The main purpose of this study is to assess the long-term safety of tazemetostat in patients who continue to receive clinical benefit from the medication. Researchers will monitor any side effects that occur over an extended period and track how well patients tolerate the medication. The study will also evaluate various health measures, including blood cell counts, kidney function, and liver function, while tracking survival outcomes. This is an open-label study, meaning all participants will receive the active medication without a placebo comparison.
Investigational drug: Tazemetostat is an oral medication taken as film-coated tablets. It belongs to a class of drugs called EZH2 inhibitors, which work by blocking the EZH2 protein that plays an important role in controlling gene expression and cancer cell growth. This targeted approach helps control the growth of certain types of cancer cells. The dosage in this trial will follow the same pattern as in each patient's previous treatment program, and treatment will continue as long as clinical benefit is observed.
Summary
For patients with recurrent malignant mesothelioma, there is currently one clinical trial available that focuses on the long-term safety evaluation of tazemetostat. This trial is particularly relevant for patients who have already participated in previous tazemetostat studies and continue to experience benefit from the treatment.
The trial is being conducted in two European countries: France and Poland. It represents an important opportunity for eligible patients to continue receiving tazemetostat while contributing to our understanding of its long-term safety profile. The study emphasizes the importance of continuous monitoring and follows an open-label design, allowing all participants to receive the active medication.
Patients interested in this trial should note that participation is limited to those who have previously been treated with tazemetostat and demonstrated clinical benefit. The study requires adequate organ function and a commitment to long-term follow-up visits. The trial is planned to continue until September 2025.
