An open label, multicenter, Phase 1/2 Study of Poly(ADP-Ribose) Polymerase (PARP) Inhibitor E7449 as Single Agent in Subjects with Advanced Solid Tumours or with B-cell Malignancies and in Combination with Temozolomide(TMZ) or with Carboplatin and Paclitaxel in Subjects with Advanced Solid Tumors

Eisai Limited0 个研究点目标入组 41 人开始时间: 2011年8月5日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Eisai Limited
入组人数: 41

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

入选标准

•1- Subjects with measurable or non-measurable disease following the Response Evaluation Critieria in Solid Tumours for Phase 1 part of the study.
•2 - Histologically and/ or cytologically confirmed advanced or metastatic solid tumor or B-cell lymphomas which have progressed after treatment with approved therapies or for which there are no standard therapies available.
•3 - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•4 - Life expectancy of >= 3 months after starting E7449
•5 - Subjects with known brain metastases will be eligible under the following conditions:
•a) have undergone complete surgical excision and are more than 1 month post surgery with no radiographic evidence of brain disease recurrence or
•b) have undergone stereotactic radio surgery (gamma knife procedure) or radiotherapy and are more than 1 month post procedure and with no radiographic evidence of brain disease progression and are asymptomatic and discontinued corticosteroid treatment at least 30 days prior to C1D1.
•6- Adequate renal function defined as Serum Creatinine <1.5xULN, or use SI units or calculated creatinine clearance >= 50mL/min per the Cockcroft-Gault formula
•7- Adequate bone marrow function (as defined in protocol)
•8 - Adequate liver function (as defined in protocol)
•9 - Left ventricular ejection fraction (LVEF) >50% on echocardiography or multiple-gated acquision (MUGA) scanning
•10 - Males or females >= 18 years at the time of informed consent
•11 - Females must not be lactating or pregnant. All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically. Females of child bearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception
•12- Male subjects must have had a succesful vasetomy (confirmed azoospermia) or they and their female partner must meet the criteria above. Those with partners using hormonal contraception must also be using an additional approved method of contraception, as described previously.
•13 - Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
•Are the trial subjects under 18? no
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

排除标准

•1 - Prior exposure to E7449
•2 - Leptomeningeal metastases or brain metastases (except as for Inclusion Criteria #5)
•3 - Prior treatment with a PARP inhibitor (Phase 2 only)
•4 - Subjects taking medications with are either strong CYP inhibitors or inducers
•5 - Subjects with a history of malignancies other than advanced ovarian cancer (Cohort 1 only), ATM-deficient B-cell lymphomas (Cohort 2 only), advanced melanoma (Cohort 3 only) or mTNBC (Cohort 4 only), will be excluded from Phase 2 unless the subject has been disease free from that additional malignancy for 5 years or the cancer was a squamous cell carcinoma of the skin, carcinoma in situ of the cervix, adequately treated Stage I or Stage II cancer from which the subject is currently in complete remission.
•6 - Subjects who have received any anticancer treatment within 4 weeks or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment
•7 - Major surgery within 4 weeks prior to the first dose of study drug
•8 - Inability to take oral medication, or malabsoption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7449
•9 - Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction or storke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment
•10 - Prolongation of QTc interval to >480 msec when electrolytes balance is normal
•11 - Active infection requiring systemic therapy
•12 - Known hypersensitivity to any component of E7449
•13 - Other relevant disease or adverse clinical conditions such as:
•history of significant neurological(no neuropathy> Grade 2) or psychiatric disorders, significant non-neoplastic liver disease, significant non-neoplastic renal disease, immunocompromised patients, including patients known to be infected with HIV, uncontrolled endocrine diseases i.e. requiring relevant changes in medication with the last month or hospital admission within the last three months, tumor bleeding
•14 - Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study
•15 - Females who are pregnant or breast feeding

研究者

发起方

Eisai Limited

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