JPRN-jRCT2031220523招募中2 期
A phase II trial of Tazemetostat for patients with unresectable or metastatic epithelioid sarcoma - TAZETTA trial
Yonemori Kan0 个研究点目标入组 15 人开始时间: 2022年12月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
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
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histopathologically diagnosed as epithelioid sarcoma
- •2) Metastatic (Stage 4 in AJCC-TNM 8th) or locally advanced disease and not curable by surgery
- •3) No leptomeningeal metastasis, symptomatic CNS metastasis or spinal metastasis requiring surgical intervention or radiotherapy
- •4) No malignant pleural effusion, cardiac effusion, or ascites requiring periodic puncture drainage
- •5) Age at the time of registration is 16 years or older
- •6) ECOG performance status of 0, 1, or 2
- •7) Having measurable disease based on RECIST 1.1 for solid tumors by CT within 14 days before registration
- •8) Having progression of unresectable or metastatic epithelioid sarcoma after at least one regimen of chemotherapy including doxorubicin
- •9) No prior exposure to tazemetostat or other inhibitor(s) of EZH
- •10) Not received cytotoxic anti-cancer drug, small molecule drug inhibitor, hormone therapy, and other studies within 21 days before registration
- •11) Not received monoclonal antibodies within 28 days before registration
- •12) Not received immune therapy within 42 days before registration
- •13) Not received operation under general anesthesia within 21 days before registration
- •14) Not received radiation therapy within 14 days before registration, stereotactic irradiation within 21 days before registration, radiation therapy to 50% of pelvis within 12 weeks before registration
- •15) Having all laboratory tests performed within 7 days before registration( Allow cardiac US performed within 14days before registration) the values are within the following range. Patients should not receive administration of G-CSF and/or blood transfusion within 14 days before the blood collection
- •(1) Absolute neutrophil count >= 1,000/mm3
- •(2) Platelet count >= 10.0 x10(4) /mm3
- •(3) Hemoglobin >= 9.0 g/dL
- •(4) Aspartate aminotransferase (AST) <= 100 U/L (allow AST <= 150 U/L in case of liver metastasis)
- •(5) Alanine aminotransferase (ALT) <= 100 U/L (allow ALT <= 150 U/L in case of liver metastasis)
- •(6) Total bilirubin <= 1.8 mg/dL
- •(7) Serum creatinine <= 1.5mg/dL x upper limit of normal (ULN) If serum creatinine >1.2 mg/dL, CCr or eGFR > 51mL/min/1.73m2
- •(8) APTT < 45 sec.
- •(9) PT < 15 sec.
- •(10) QTc corrected by Fridericia's correction <= 480msec
- •(11) Left ventricular ejection fraction >= 50% by echocardiography
- •16) Consent to contraception and limited breast-feeding
- •17) Written informed consent (When registering a minor patient, a signed consent form must be obtained from both the patient and the parent or legal guardian.)
排除标准
- •1) Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 2 years).
- •2) History of T-LBL/T-ALL or myeloid hematologic malignancy
- •3) Infections requiring systemic treatment
- •4) Diagnosed as immunodeficiency disease
- •5) Active gastrointestinal ulceration
- •6) Current or previous interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings
- •7) Current or previous severe hypersensitive reaction to ingredients including tazemetostat
- •8) A medical need for the continued use of potent inhibitors of CYP3A, or potent inducer of CYP3A (including St. John's wort). (eligible if 2 weeks or longer have passed since the last use of such agents prior to the first dose of study drugs.)
- •9) Unable to refrain from grapefruit (including juice) from 1 week prior to study drug administration and throughout the study
- •10) Patients with any of the following history of cardiovascular impairment
- •(1) Congestive heart failure of >= New York Heart Association (NYHA) Class II
- •(2) Uncontrolled arterial hypertension
- •(3) Unstable angina, myocardial infarction, or stroke within 6 months before registration
- •(4) Cardiac arrhythmia requiring medical treatment
- •11) HIV antibody-positive, HBs antigen-positive, or HCV RNA-positive (those who are HCV-RNA-negative are not excluded even if HCV antibody-positive)
- •12) Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive (Not excluded if HBV-DNA is below detection sensitivity)
- •13) Poorly controlled venous thrombus within 14 days before registration
- •14) Pregnant or breast-feeding women, or women suspected of being pregnant
- •15) Psychiatric diseases or psychological symptoms interfering with participation in the trial
研究者
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