Actively Recruiting
Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma
Led by University of Washington · Updated on 2026-03-30
18
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older with newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma confirmed by specific testing
- Presence of a measurable tumor lesion assessed by CT or MRI
- Tumor judged to be surgically removable at enrollment
- Plan to undergo neoadjuvant radiation therapy followed by surgery, with treatment plans reviewed and approved by a radiation oncologist
- Adequate blood counts without recent blood transfusions or growth factor support
- Liver enzymes and bilirubin within defined limits
- Serum albumin level of 2.8 g/dl or higher
- Kidney function within specified limits
- Urine protein/creatinine ratio below threshold
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Male or non-pregnant, non-breastfeeding female with agreement to use effective contraception if applicable
- Life expectancy greater than 3 months
- Ability to understand and sign informed consent
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- Previous cytotoxic, biologic, or systemic anticancer therapy for this diagnosis
- Prior radiation therapy to the affected area
- Known brain metastases
- Evidence of distant metastatic disease
- History of blood clots or thromboembolic events within 1 year
- History of certain heart rhythm problems or sudden cardiac arrest
- Major surgery within 14 days before enrollment
- Ongoing anticoagulation treatment related to previous blood clots
- History of interstitial lung disease
- Serious uncontrolled medical conditions that would prevent study participation
- Pregnant or breastfeeding women
- Inability to swallow tablets
- Known allergy or sensitivity to study treatments
- Diagnosis of another cancer within 2 years except certain cured or localized tumors
- Use of medications that interact unsafely with abemaciclib that cannot be stopped
- Recent infection requiring systemic treatment within 14 days (except uncomplicated infections)
- Active systemic bacterial, fungal, or viral infections
- Participation in other medical research studies judged incompatible by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
D
David Siu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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