Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

Epizyme, Inc.0 个研究点目标入组 100 人开始时间: 2018年6月20日最近更新: 2024年6月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Epizyme, Inc.
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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 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
•3. Has voluntarily provided signed written informed consent/assent and demonstrated willingness and ability to comply with all aspects of the
•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
•6. For French subjects only: Is either affiliated with or a beneficiary of a social security category
•7. 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.
•8. 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.
•9. 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

排除标准

•1. Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study
•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. Has an 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.
•9. For female subjects of childbearing potential: Is pregnant or nursing
•10. Has been permanently discontinued from tazemetostat therapy due
•to adverse event, intolerance or treatment failure

研究者

发起方

Epizyme, Inc.

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