Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Ewing’s Sarcoma
- Conditions
- Ewing's SarcomaMedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-004734-11-DE
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
- Diagnosis of Ewing’s sarcoma or Ewing’s sarcoma-like tumor
- 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
- Female patients of childbearing potential must have a negative urine or
serum pregnancy test within 7 days prior to Cycle 1 Day 1. For France,
serum pregnancy test must be performed.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Have received any prior CDK4 and 6 inhibitor
- Progression during prior treatment with irinotecan or temozolomide
- Currently enrolled in a clinical study involving an investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study
- A serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To evaluate the safety profile of abemaciclib, irinotecan, and temozolomide combination<br>To characterize the clinical activity of the abemaciclib, irinotecan, and temozolomide combination<br>To characterize the PK of the abemaciclib in combination with irinotecan +temozolomide<br>To assess the acceptability and palatability of the age-appropriate tablet and/or granule drug product, including dispersed tablets <br>and/or granules;Primary end point(s): PFS as determined by BIRC using RECIST 1.1<br>;Timepoint(s) of evaluation of this end point: When approximatively 34 PFS events out of the 45 randomized participants will have been observed by blinded independent review committee. ;Main Objective: To characterize the efficacy of abemaciclib in combination with irinotecan + temozolomide<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety (including but not limited to): TEAEs, SAEs, deaths, laboratory<br>abnormalities, vital signs, and physical examinations<br>OS<br>ORR<br>DoR<br>DCR<br>PFS as determined by investigator <br>Concentrations of abemaciclib<br>Assessment of tablet, granule, or dispersed drug product presentation, including acceptability and palatability<br><br>;Timepoint(s) of evaluation of this end point: When approximatively 34 PFS events out of the 45 randomized participants will have been observed by blinded independent review committee. <br>At the end of the study.