NCT06025747

Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma

A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.

Detailed description

OUTLINE: This is a dose-escalation study of abemaciclib. Prior to surgery, patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy over 28 fractions starting on cycle 1 day 15 in the absence of disease progression or unacceptable toxicity. After completion of radiation therapy, patients may undergo surgery. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Retroperitoneal Sarcoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Given PO
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
RADIATION	Radiation Therapy	Undergo radiation therapy
PROCEDURE	Therapeutic Surgical Procedure	Undergo surgery

Timeline

• Start date: 2025-03-19
• Primary completion: 2027-03-03
• Completion: 2029-03-03
• First posted: 2023-09-06
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study