A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable teratoma with recent progression

ovartis Pharma Services AG0 个研究点目标入组 90 人开始时间: 2015年1月8日最近更新: 2018年4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: ovartis Pharma Services AG
入组人数: 90

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.Age = 15 years old at time of informed consent.
•2.Diagnosis of teratoma for which no additional standard surgical or medical therapy exists
•3.Availability of an archival tumor biopsy specimen (collected at diagnosis or progression) with accompanying pathology report
•Patients without an archival tumor sample may be permitted to participate after discussion between Novartis and the investigator
•4.Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor
•5.If malignant transformation is present then chemotherapy appropriate for malignant transformation histology must have been given
•6. Radiographic progression, defined by RECIST v.1.1, after the last cancer treatment and within 12 weeks prior to enrollment, compared with scans within 1 year of enrollment.
•7.Measurable or evaluable extra-cranial disease as defined by RECIST v.1.1
•8.Patients must have ECOG performance status of 0-1
•Other criteria may apply.
•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 85
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1.CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of 3 months demonstrates stable disease. Patient must be asymptomatic and without need for treatment with systemic corticosteroids or anti-epileptic medications
•2.Malignant germ cell tumors other than that being treated in this study, including tumors with elements of mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or seminoma
•3.Concurrent malignancy other than teratoma or malignancy within 3 years of randomization, with the exception of adequately treated basal or squamous cell carcinoma of the skin, curatively resected cervical cancer or curatively resected carcinoma in situ of any type
•4.Prior treatment with any CDK4/6 inhibitor therapy
•5.Any concurrent severe and/or uncontrolled medical condition that, in the investigator’s judgment serves as a contraindication to patient participation (e.g., chronic pancreatitis, active hepatitis, viral hepatitis or known HIV positivity. Baseline HIV screening is not required
•6.Patients who have not recovered to = CTCAE grade 1 from the acute toxic effects (except for alopecia) of all prior chemotherapy, immunotherapy, or radiotherapy
•7.Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
•8.Impaired cardiac function or any clinically significant cardiac disease, including any of the following
•Left ventricular ejection fraction (LVEF) < 45% or less than the institution’s lower limit of normal as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO)
•Congenital long QT syndrome or family history of unexpected sudden cardiac death
•QT corrected with Fredericia’s (QTcF) QTcF >450 msec for males and >470 msec for females on screening ECG
•Clinically significant heart disease such as CHF requiring treatment (NYH grade = 2), unstable angina pectoris or myocardial infarction within the past 3 months. Any other clinically significant heart disease such as unstable arrhythmia, resting bradycardia, right bundle branch block, bifascicular block, or any heart disease that requires the use of a cardiac pacemaker = 3 months prior to starting study drug
•Patients who are currently receiving medications with known risk of prolonging the QT interval or inducing Torsades de Pointes and are unable to discontinue or switch to an alternate medication
•9.Concomitant therapy that precludes enrollment
•Systemic antineoplastic therapy or any experimental therapy within 3 weeks before the first dose of study drug (6 weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
•Systemic corticosteroids within 2 weeks prior to starting study drug. Note: Corticosteroids are permitted for use as single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
•10.Major surgery within 2 weeks prior to planned start of study drug or patient has not recovered from major side effects of the surgery
•11.Received radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to randomization, or patient has not recovered to = CTCAE grade 1 related toxicity
•12.Requirement for treatment with any of the prohibited medications in

研究者

发起方

ovartis Pharma Services AG

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