2023-506772-28-00招募中2 期
J1S-MC-JP04: A Randomized, Open-Label Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Relapsed or Refractory Ewing’s Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 16
- 主要终点
- Progression Free Survival as determined by blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
研究概览
简要总结
The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) for Ewing's sarcoma that has come back or did not respond to treatment.
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor
- •Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to Cycle 1 Day
- •Confirmed radiological progression or refractory disease or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor, and must have one measurable or evaluable lesion per RECIST 1.1
- •Participants aged 1 to <40 years
- •Body weight ≥10 kg
- •Adequate performance status based on age. For participants <16 years of age, a Lansky score ≥50, or for participants ≥16 years of age, a Karnofsky score ≥50
- •The participant has adequate hematologic and organ function ≤14 days prior to Day 1 of Cycle 1
- •Must be able to swallow and/or have a gastric/nasogastric tube.
- •Participants in the European Union must be able to swallow intact capsules.
- •Discontinued all previous treatments for cancer or investigational agents and recovered from the acute effects to Grade ≤1 at the time of enrollment
排除标准
- •Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- •Diagnosed and/or treated additional malignancy within 3 years prior to enrollment
- •Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
- •Participants who have had allogeneic bone marrow or solid organ transplant
- •Surgery: Participants who have had, or are planning to have, the following invasive procedures: Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment
- •Surgical or other wounds must be adequately healed prior to enrollment
- •Female participants who are pregnant or breastfeeding
- •Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
- •Progression during prior treatment with irinotecan and/or temozolomide
- •Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
结局指标
主要结局
Progression Free Survival as determined by blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
Progression Free Survival as determined by blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (16)
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