Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Ewing’s Sarcoma

Protocol Addendum 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004734-11-FR

Enrollment

Registered

2022-05-13

Start date

2022-08-22

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ewing's Sarcoma MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Abemaciclib Product Code: LY2835219 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LY2835219 Other descriptive name: Abemaciclib Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis of Ewing’s sarcoma or Ewing’s sarcoma-like tumor - Confirmed radiological progression or refractory disease and must have one measurable or evaluable lesion per RECIST 1.1 - Participants aged 1 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the efficacy of abemaciclib in combination with irinotecan + temozolomide ;Secondary Objective: To evaluate the safety profile of abemaciclib, irinotecan, and temozolomide combination To characterize the clinical activity of the abemaciclib, irinotecan, and temozolomide combination To characterize the PK of the abemaciclib in combination with irinotecan +temozolomide To assess the acceptability and palatability of the age-appropriate tablet and/or granule drug product, including dispersed tablets and/or granules;Primary end point(s): PFS as determined by BIRC using RECIST 1.1 ;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.	—

Measure

Time frame

Main Objective: To characterize the efficacy of abemaciclib in combination with irinotecan + temozolomide ;Secondary Objective: To evaluate the safety profile of abemaciclib, irinotecan, and temozolomide combination To characterize the clinical activity of the abemaciclib, irinotecan, and temozolomide combination To characterize the PK of the abemaciclib in combination with irinotecan +temozolomide To assess the acceptability and palatability of the age-appropriate tablet and/or granule drug product, including dispersed tablets and/or granules;Primary end point(s): PFS as determined by BIRC using RECIST 1.1 ;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.

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Secondary

Measure	Time frame
Secondary end point(s): Safety (including but not limited to): TEAEs, SAEs, deaths, laboratory abnormalities, vital signs, and physical examinations OS ORR DoR DCR PFS as determined by investigator Concentrations of abemaciclib Assessment of tablet, granule, or dispersed drug product presentation, including acceptability and palatability ;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. At the end of the study.	—

Measure

Time frame

Secondary end point(s): Safety (including but not limited to): TEAEs, SAEs, deaths, laboratory abnormalities, vital signs, and physical examinations OS ORR DoR DCR PFS as determined by investigator Concentrations of abemaciclib Assessment of tablet, granule, or dispersed drug product presentation, including acceptability and palatability ;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. At the end of the study.

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Countries

Australia, France, Germany, Italy, Japan, Spain, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026