A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) inPediatric 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).

Eli Lilly and Company0 个研究点目标入组 60 人开始时间: 2020年8月12日最近更新: 2024年6月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Eli Lilly and Company
入组人数: 60

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

•- Participants must be =18 years of age at the time of study enrollment
•- 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. Neurologic
•deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment.
•a. Patients must have at least one measurable (per RECIST v1.1
•[Eisenhauer et al. 2009] or RANO for CNS tumors [Wen et al. 2010]) or evaluable lesion.
•b. Patients must have had histologic verification of malignancy at
•original diagnosis or relapse, except:
•i. patients with extra-cranial germ-cell tumors who have elevations of
•serum tumor markers including alpha-fetoprotein or beta-HCG.
•ii. patients with intrinsic brain stem tumors or patients 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, and 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 intact capsules.
•- Adequate hematologic and organ function =2 weeks (14 days) prior to first dose of study drug.
•- Females of reproductive potential must have negative serum pregnancy test at baseline (within 7 days prior to starting treatment).
•- Both female and male participants of reproductive potential must agree to use highly effective contraceptive precautions (and avoid sperm donation for males) during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib dose (males have no restriction for contraceptive use following treatment with 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 are willing to make themselves available for the duration of the trial.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

排除标准

•- Received allogenic bone marrow or solid organ transplant.
•- Received live vaccination (within 4 weeks prior to starting study treatment).
•- Participants with psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol.
•- 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.
•- Intolerability or hypersensitivity to any of the study treatments or its components relevant to the study part that is currently enrolling or a known hypersensitivity to dacarbazine.
•- 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 or viral load.
•- Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea).
•- Treated with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of UGT1A1 if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
•- 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.
•- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
•-Tumor contains known somatic or germline RB (retinoblastoma) mutation. Screening is not required for enrollment.
•-Participants with a bowel obstruction will be excluded from Part A of this study.

研究者

发起方

Eli Lilly and Company

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