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

ovartis0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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 or newly obtained tumor sample accompanying pathology report.
•* Patients without a 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. 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.
•6. Measurable or evaluable extra-cranial disease as defined by RECIST v.1.1.
•7. Patients must have ECOG performance status of 0-1.
•8. Written informed consent/assent before any study-specific screening procedures.

•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 2 months demonstrates stable disease.
•2. Malignant germ cell tumors other than that being treated in this study
•3. Concurrent malignancy other than teratoma within 3 years of randomization
•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
•6. Patients who have not recovered to * CTCAE grade 1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy.

发起方