Ongoing Clinical Trials for Neurofibrosarcoma
Currently, there is 1 ongoing clinical trial focused on neurofibrosarcoma. This trial evaluates the long-term safety of tazemetostat, an investigational medication, in patients who have previously participated in tazemetostat studies and have shown benefit from the treatment. 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 designed to monitor the long-term safety of tazemetostat in patients who have already been treated with this medication in previous clinical studies and have experienced clinical benefit. The study will track how well patients tolerate the medication over an extended period and monitor for any side effects that may develop during continued treatment.
Inclusion criteria: To participate in this trial, you must currently be receiving tazemetostat treatment and benefiting from it. The medication may be taken alone or in combination with other approved or experimental treatments. You must have a life expectancy of more than 3 months and demonstrate 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 the start of the study and agree to use highly effective birth control methods plus a barrier method during treatment and for 6 months afterward. Men must either have had a vasectomy and remain abstinent or use effective contraception, including condoms, throughout the study and for 3 months after stopping treatment.
Exclusion criteria: You cannot participate if you are not currently receiving tazemetostat in a previous clinical study, or if you experienced severe side effects during previous treatment with this medication. Patients who cannot comply with long-term safety monitoring requirements, who have developed medical conditions that make continued treatment unsafe, or who have withdrawn consent from their previous tazemetostat study are not eligible. Additionally, you cannot participate if you have missed scheduled doses, failed to follow study procedures in your previous trial, developed progressive disease while on tazemetostat, are participating in other clinical trials simultaneously, have developed contraindications to tazemetostat treatment, or cannot attend long-term follow-up visits as required.
Focus of the trial: The main goal of this study is to evaluate the long-term safety of tazemetostat when used continuously by patients who have shown benefit from the treatment in previous trials. Researchers will carefully monitor participants for any side effects and track various health measures including blood cell counts, kidney function, and liver function. The study will also monitor how long patients survive while receiving the treatment. Treatment will continue according to each patient’s previous treatment plan, and participation will last as long as the patient continues to show clinical benefit. The study is planned to continue until September 2025.
Investigational drug: Tazemetostat is an oral medication given as a film-coated tablet. It belongs to a class of drugs called EZH2 inhibitors, which work by blocking the EZH2 protein that plays a crucial role in controlling gene expression and cancer cell growth. This medication targets specific enzymes in cancer cells to help control the growth of certain types of tumors. Tazemetostat represents an innovative approach in targeted cancer therapy and is primarily used in the treatment of certain types of lymphomas and solid tumors, showing particular effectiveness in patients with specific genetic mutations.
Summary
There is currently one ongoing clinical trial for neurofibrosarcoma, which is being conducted in two European countries: France and Poland. This trial focuses specifically on monitoring the long-term safety of tazemetostat in patients who have already participated in previous tazemetostat studies and have experienced clinical benefit. The trial does not recruit new patients who have never received tazemetostat before, but rather provides continued access to the medication for those who have responded well to it in previous research studies. The study emphasizes careful monitoring of side effects and various health parameters over an extended period, with the goal of understanding how well patients tolerate this medication when taken for a longer duration. This type of trial is important for understanding the safety profile of new medications beyond the initial treatment period.