NL-OMON50516已完成2 期
A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma - EZH-102
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Age (at time of consent/assent): *6 months to *18 years
- •Cohort 4 only: *10 years to *18 years
- •2. Performance Status:
- •If <12 years of age: Lansky Performance Status >50%
- •If *12 years of age: Karnofsky Performance Status >50%
- •3. Has provided signed written informed consent/assent
- •4. Has a life expectancy of >3 months
- •5. Has relapsed or refractory disease and no standard treatment options
- •6. Is ineligible or inappropriate for other treatment regimens known to have
- •effective potential
- •7. Has a documented local diagnostic pathology of original biopsy
- •8. Has all prior treatment related clinically significant toxicities resolve
- •to * Grade 1 per CTCAE, version 4.03 or are clinically stable and not
- •clinically significant, at time of enrollment
- •9. Prior therapy(ies), must be completed according to the protocol
- •10. Has adequate hematologic BM & coagulation factors), renal & hepatic
- •function as defined by criteria in the protocol
- •11. Specific requirements for subjects with CNS involvement eg: stable deficits
- •within certain timeframe, stable seizure, treated brain metastases without
- •evidence of progression.
- •12. Has a LV fractional shortening of >27% or an LV ejection fraction of *50%
- •by ECHO or MUGA scan & NYHA *2
- •13. Has a QT interval corrected by Fridericia's formula (QTcF) *450 msec
- •14. Is able to swallow and retain orally administered medication and does not
- •have any uncontrolled GI condition that may alter absorption
- •15. Has sufficient tumor tissue available for central confirmatory testing of
- •IHC and/or cytogenetics/FISH and/or DNA mutation analysis
- •16. Is willing and able to comply with all aspects of the protocol as judged by
- •Investigator
- •17. 18. For female subjects of childbearing potential and for male subjects
- •with a female partner of childbearing potential Subject must adhere to
- •contraception methods described in the protocol
- •For Dose Escalation Only:
- •All criteria above and the following:
- •1. Has evaluable disease as defined as lesions that can be accurately measured
- •at least in one dimension by radiographic examination or physical examination
- •or/and other lesions such as bone lesions, leptomeningeal disease, ascites,
- •pleural/pericardial effusions, lymphangitis cutis/pulmonitis or
- •hepatosplenomegaly from disease.
- •2. Has one of the following histologically confirmed tumors: Rhabdoid tumor:
- •ATRT, MRT, RTK, selected tumors with rhabdoid features, INI1-negative tumor
- •(Epithelioid sarcoma, Epithelioid malignant peripheral nerve sheath tumor, EMC,
- •Myoepithelial carcinoma, Renal medullary carcinoma), other INI1-negative
- •malignant tumors, Synovial sarcoma with SS18-SSX rearrangement.
- •3. For subjects with ATRT, MRT, or RTK, or tumors with rhabdoid features only:
- •the following test results must be available:
- •*Morphology and immunophenotypic panel consistent with rhabdoid tumor, and
- •*Loss of INI1 or SMARCA4 confirmed by IHC, or
- •*Molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation
- •when INI1 or SMARCA4 IHC is equivocal or unavailable
- 另有 5 项未显示
排除标准
- •1. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of
- •zeste homolog2 (EZH2)
- •2. Is being actively treated for another concurrent malignancy or is less than
- •five years from completion of treatment for another malignancy
- •3. Has participated in another interventional clinical study and received
- •investigational drug within 30 days or five half-lives, whichever is longer,
- •prior to the planned first dose of tazemetostat
- •4. Has had major surgery within 2 weeks prior to enrollment
- •5. Has clinically active heart disease including prolonged QTcF (>450 msec)
- •6. Is currently taking any prohibited medication(s) as described in section 7.3
- •7. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit
- •from the diet and all foods that contain those fruits from time of enrollment
- •to while on study
- •8. Has an active infection requiring systemic treatment
- •9. Is immunocompromised (ie congenital immunodeficiency), including subjects
- •with known history of infection with human immunodeficiency virus (HIV)
- •10. Has known history of chronic infection with hepatitis B virus (hepatitis B
- •surface antigen positive) or hepatitis C virus (detectable HCV RNA)
- •11. Has had a symptomatic venous thrombosis within 14 days prior to study
- •12. For subjects with CNS involvement (primary tumor or metastatic disease):
- •Have any active bleeding, or new intratumoral hemorrhage of more than punctate
- •size on Screening MRI obtained within 14 days of starting study drug,or known
- •bleeding diathesis or treatment with anti-platelet or anti-thrombotic agents
- •13. Has known hypersensitivity to any of the components of tazemetostat or
- •other inhibitor(s) of EZH2, or hypersensitivity to Ora-sweet or methylparaben
- •14. Has an uncontrolled intercurrent illness including, but not limited to,
- •uncontrolled infection, or psychiatric illness/social situations that would
- •limit compliance with study requirements
- •15. For female subjects of childbearing potential: Is pregnant or nursing
- •16. For male subjects: Is unwilling to adhere to contraception criteria from
- •time of enrollment in study to at least 3 months after last dose of
- •tazemetostat.
研究者
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