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

Epizyme, Inc.0 个研究点目标入组 300 人开始时间: 2016年10月6日最近更新: 2024年6月3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: 300

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 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 provided signed written informed consent
•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 childbearing potential must:
•Have a negative beta-human chorionic gonadotropin (ß-hCG) pregnancy test at time of study entry and within 14 days prior to planned first dose of investigational product, and
•Agree to use effective contraception, as defined in Section 10.4 until 30 days following the last dose of investigational product and have a male partner who uses a condom, or
•Practice true abstinence (when this is in line with the preferred and usual lifestyle of the subject, see Section 10.4.1), or
•Have a male partner who is vasectomized.
•8. Male subjects with a female partner of childbearing potential must:
•Be vasectomized, or
•Agree to use condoms as defined in Section 10.4.2 until 30 days following the last dose of investigational product, or
•Have a female partner who is NOT of childbearing potential.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 255
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

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 any 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. 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.
•4. Is currently taking any prohibited medication(s) as described in Section 8.3.
•5. 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
•6. Has an uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements.
•7. For female subjects of childbearing potential: Is pregnant or nursing
•8. 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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