In short
There is currently 1 ongoing clinical trial for patients with rhabdoid tumour of the kidney. This trial focuses on the long-term safety of tazemetostat, a targeted medication, in patients who have previously benefited from this treatment in earlier clinical studies. The trial is being conducted in France and Poland.
Clinical trial locations
- France
- Poland
Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials
This trial is evaluating the long-term safety of tazemetostat, a medication taken as a film-coated tablet by mouth. The study is designed for patients who have previously received tazemetostat in other clinical trials and have shown benefit from the treatment. Researchers will monitor patients who continue taking tazemetostat either alone or in combination with other approved or experimental medications.
Main inclusion criteria:
- Currently benefiting from treatment with tazemetostat
- Currently receiving tazemetostat either alone or in combination with other medications as part of a clinical trial
- Life expectancy of more than 3 months
- Adequate blood cell counts, bone marrow function, blood clotting factors, kidney function, and liver function
- Women who can become pregnant must have a negative pregnancy test at study entry and 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
- Men must either 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
Main exclusion criteria:
- Not currently receiving tazemetostat treatment in a previous clinical study
- Experienced severe side effects during previous treatment with tazemetostat
- Unable to comply with the long-term safety monitoring requirements
- Developed any medical condition that makes continued treatment unsafe
- Withdrawn consent from their previous tazemetostat study
- Missed scheduled doses or failed to follow study procedures in their previous trial
- Developed progressive disease while on tazemetostat treatment
- Participating in other clinical trials simultaneously
- Developed any contraindications to tazemetostat treatment
Focus and goal of the trial: The primary aim of this study is to assess the long-term safety of tazemetostat in patients who continue to benefit from this treatment. Researchers will monitor any side effects that may occur and how well patients tolerate the medication over an extended period. The study will track various health measures, including blood cell counts, kidney function, and liver function. Additionally, researchers will monitor 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. The study is planned to continue until September 2025.
Investigational drug: Tazemetostat is an oral medication administered in tablet form. It belongs to a class of drugs called EZH2 inhibitors, which help control the growth of certain types of cancer cells by blocking the EZH2 protein. This protein plays a crucial role in controlling gene expression and cancer cell growth. Tazemetostat represents an innovative approach in targeted cancer therapy and has shown effectiveness in patients with specific genetic mutations. The medication will be provided according to each patient's previous treatment plan.
Summary
Currently, there is one clinical trial available for patients with rhabdoid tumour of the kidney. This trial is focused on evaluating the long-term safety of tazemetostat, a targeted therapy that works by blocking specific enzymes in cancer cells. The trial is particularly notable as it is designed for patients who have already participated in previous tazemetostat studies and have shown clinical benefit from the treatment.
The trial is being conducted in two European countries: France and Poland. This geographic distribution provides access to patients in Western and Central Europe who meet the eligibility criteria. The study represents a continuation of care for patients who are benefiting from tazemetostat, allowing them to continue receiving treatment while being closely monitored for long-term safety.
The focus on long-term safety monitoring is particularly important for rare cancers such as rhabdoid tumour of the kidney, as it helps researchers understand how patients tolerate the medication over extended periods and whether any new side effects emerge with prolonged use. This information is valuable for both current patients and future treatment guidelines.
