JPRN-jRCT2031210562招募中1 期
A Phase 1b Dose Escalation Study of Abemaciclib in Combination With Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors - I3Y-MC-JPCS
Masaki Takeshi0 个研究点目标入组 60 人开始时间: 2022年1月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- ot applicable 至 <= 18age old（—）
- 性别
- All
入选标准
- •Body weight >=10 kilograms and body surface area (BSA) >=0.5 meters squared.
- •Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies and, in the judgment of the investigator, are appropriate candidates for the experimental therapy combination in the study part that is currently enrolling.
- •Participants must have at least one measurable (per Response Criteria in Solid Tumors [RECIST v1.1; [Eisenhauer et al. 2009] or Response Assessment in Neuro-Oncology (RANO) for central nervous system (CNS) tumors [Wen et al. 2010]) or evaluable lesion.
- •Participants must have had histologic verification of malignancy at original diagnosis or relapse, except:
- •Participants with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta- human chorionic gonadotropin (HCG).
- •Participants with intrinsic brain stem tumors or participants with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG.
- •A Lansky score >=50 for participants <=16 years of age or Karnofsky score >=50 for participants >16 years of age.
- •Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade <=1 at the time of enrollment.
- •Able to swallow.
排除标准
- •Received allogenic bone marrow or solid organ transplant.
- •Have a personal history of any of the following conditions within the last 12 months: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- •Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.
- •Pregnant or breastfeeding.
- •Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
- •Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.
- •Tumor contains known somatic or germline retinoblastoma (RB) mutation.
研究者
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