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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
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506772-28-00
Acronym
J1S-MC-JP04
Enrollment
30
Registered
2024-03-04
Start date
2022-10-07
Completion date
2025-07-19
Last updated
2025-04-30

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

Conditions

Ewings Sarcoma

Brief summary

Progression Free Survival as determined by blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)

Interventions

DRUGVerzenios 50 mg film-coated tablets
DRUGTEMOZOLOMIDE
DRUGIRINOTECAN
DRUGAbemaciclib

Sponsors

Eli Lilly & Co.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Progression Free Survival as determined by blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026