EUCTR2014-000428-12-NL进行中（未招募）1 期
A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable teratoma with recent progression
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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. Diagnosis of teratoma for which no additional standard surgical or medical therapy
- •2. Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor
- •3. 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.
- •4. Availability of an archival or newly obtained tumor sample (collected at diagnosis or progression) with accompanying pathology report
- •5. Measurable or evaluable extra-cranial disease as defined by RECIST v 1.1
- •Other protocol-defined inclusion criteria may apply
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Malignant germ cell tumors with mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or
- •2. Pathologic evidence of malignant transformation
- •3. CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation demonstrates stable disease
- •4. Prior treatment with any CDK4/6 inhibitor therapy
- •5. 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)
- •6. Major surgery = 2 weeks or radiotherapy = 4 weeks prior to planned start of study drug or patient has not
- •recovered from major side effects.
- •7. Requirement for treatment with any of the prohibited medications including strong CYP3A4/5 inhibitors, strong CYP3A4/5 inducers, CYP3A4/5 substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation.
- •Other protocol-defined Exclusion criteria may apply
研究者
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