Informations générales (source: ClinicalTrials.gov)
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
Interventional
Phase 1/Phase 2
Epizyme, Inc. (Voir sur ClinicalTrials)
août 2016
novembre 2025
12 septembre 2025
This study will provide continuing availability to tazemetostat for people that have
previously completed participation in a tazemetostat study, either with monotherapy
(single drug treatment) or combination therapy.
The aim of the study will be to assess the long-term safety of tezemetostat.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 10/04/2024 12:48:58 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Henri Becquerel - 76038 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - 69310 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| CHRU de Lile- Hopital Claude Huriez - 59037 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Caen - Hôpital Côte de Nacre - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Montpellier - Hopital Saint Eloi - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes- Hopital Pontchaillou - 35033 - Rennes Cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Louis - AP-HP - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Subjects must meet ALL criteria to be eligible for enrollment in this study.
2. Has demonstrated and continues to demonstrate clinical benefit from treatment with
tazemetostat.
3. Is currently receiving tazemetostat as either monotherapy or in combination with
other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical
trial or any other clinical trial being conducted with tazemetostat that is not
sponsored by Epizyme (including but not limited to, investigator-initiated trials).
For subjects on combination therapy, treatment with other therapeutic(s) must have
been completed in the antecedent study or will be provided by a source other than
Epizyme if combination therapeutics are continued in this study until disease
progression, treatment toxicity, subject preference or death, up to approximately 7
years.
4. Has voluntarily provided signed written informed consent and demonstrated
willingness and ability to comply with all aspects of the protocol.
5. Has a life expectancy of ≥3 months.
6. Has adequate hematologic, (bone marrow [BM] and coagulation factors), renal, and
hepatic function. Subject must remain eligible for continued treatment with
tazemetostat according to the eligibility and treatment criteria from the antecedent
study
1. Subjects must meet ALL criteria to be eligible for enrollment in this study.
2. Has demonstrated and continues to demonstrate clinical benefit from treatment with
tazemetostat.
3. Is currently receiving tazemetostat as either monotherapy or in combination with
other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical
trial or any other clinical trial being conducted with tazemetostat that is not
sponsored by Epizyme (including but not limited to, investigator-initiated trials).
For subjects on combination therapy, treatment with other therapeutic(s) must have
been completed in the antecedent study or will be provided by a source other than
Epizyme if combination therapeutics are continued in this study until disease
progression, treatment toxicity, subject preference or death, up to approximately 7
years.
4. Has voluntarily provided signed written informed consent and demonstrated
willingness and ability to comply with all aspects of the protocol.
5. Has a life expectancy of ≥3 months.
6. Has adequate hematologic, (bone marrow [BM] and coagulation factors), renal, and
hepatic function. Subject must remain eligible for continued treatment with
tazemetostat according to the eligibility and treatment criteria from the antecedent
study
Subjects meeting ANY of the following criteria must NOT be enrolled in this study:
1. Has had an interruption of tazemetostat dosing of >14 days from the antecedent
clinical study to starting the rollover study unless approved by the Medical
Monitor.
2. Has another malignancy other than the one for which they are receiving tazemetostat.
• Exception: Subject who has been disease-free of a prior malignancy for 5 years or
subject with a history of a completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma is eligible.
3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or
any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
4. Has a prior history of T-LBL/T-ALL.