A Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Ewing's Sarcoma
- Conditions
- Ewings SarcomaTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506772-28-00
- Lead Sponsor
- Eli Lilly & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 41
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 1., 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method