ROLLOVER STUDY FOR TAZEMETOSTAT

Laborértékek

• Has been permanently discontinued from tazemetostat therapy due to adverse event, intolerance or treatment failure.
  • 2.Has an other 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.
  • 5.Is unwilling to exclude grapefruit juice, Seville oranges, and grapefruit from the diet and all foods that contain those fruits from time of enrollment throughout their participation in the study.
  • 6.Is currently taking any prohibited medication(s) as described in Section 10.3
  • 7.Is unable to take oral medications, has malabsorption syndrome, or has any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of tazemetostat
  • 8.Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant bleeding diathesis or coagulopathy including known platelet function disorders, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias or psychiatric illness/social situations that would limit compliance with study requirements
  • 8.Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant bleeding diathesis or coagulopathy including known platelet function disorders, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias or psychiatric illness/social situations that would limit compliance with study requirements

Egyéb

• 1.Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study

• 1.Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
• 2.Is currently receiving or is in survival follow-up having previously received tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizymesponsored 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
• 3.Has voluntarily provided signed written informed consent/assent and demonstrated willingness and ability to comply with all aspects of the protocol
• 4.Has a life expectancy of >3 months
• 5.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
• Female subjects of reproductive potential must have a negative urine/serum pregnancy test upon study entry. Female subjects who are of non-reproductive potential (ie, post- menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) are exempt from pregnancy testing.
• Female subjects of reproductive potential who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (eg, condoms, cervical ring, sponge, etc) during the period of therapy and for 6 months after the last dose of tazemetostat. It is recommended that barrier methods be supplemented with the use of a spermicide.
• Male subjects must have had either a successful vasectomy AND remain abstinent/practice highly effective contraception and use a condom throughout the study period and for 3 months after tazemetostat discontinuation OR they and their female partner must meet the criteria above ie, not of childbearing potential.