A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Dis… (NCT02875548) | Clinical Trial Compass
CompletedPhase 1/2
A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study
United States58 participantsStarted 2016-08-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must meet ALL criteria to be eligible for enrollment in this study.
✓. Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
✓. 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.
✓. Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
✓. Has a life expectancy of ≥3 months.
✓. 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
Exclusion criteria
✕. 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.
✕. Has another malignancy other than the one for which they are receiving tazemetostat.
What they're measuring
1
Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
Timeframe: Until end of study an average of 7 years
2
Duration of Study Drug Exposure
Timeframe: Until end of study an average of 7 years
. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).