CTIS2023-506778-11-00进行中（未招募）1 期
I3Y-MC-JPCS: A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C). - I3Y-MC-JPCS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
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
- 0 至 64（—）
- 性别
- All
入选标准
- •Parts A and B only: Participants must be less than or equal to (=)18 years of age. Body weight greater than or equal to (=)10 kilograms and body surface area (BSA) =0.5 Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies. For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS., Part C only: Participants must be less than (<) 21 years of age. Participants have a BSA =0.2 m². Participants with first relapse/refractory neuroblastoma., All Parts Participants must have measurable or evaluable disease by RECIST v1.1 or RANO. 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 and/or have a gastric/nasogastric tube. Adequate hematologic and organ function =2 weeks (14 days) prior to first dose of study drug. Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment). Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label. Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment. Caregivers and participants willing to make themselves available for the duration of the trial.
排除标准
- •Received allogenic bone marrow or solid organ transplant., Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor, Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma., Part C only, have received prior anti-GD2 therapy during induction phase., Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device., Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer., Received live vaccination., Intolerability or hypersensitivity to any of the study treatments or its components., 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., Active systemic infections., Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study., Parts A and C only: Have a bowel obstruction., Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
研究者
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