Actively Recruiting
A Phase 1 Study of Neoadjuvant Abemaciclib Combined With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas
Led by University of Washington · Updated on 2026-06-04
18
Participants Needed
1
Research Sites
104 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
Researchers are evaluating the safety, side effects, and optimal dose of abemaciclib combined with radiation therapy before surgery in patients with high-risk adipocytic retroperitoneal sarcoma. This phase I trial aims to see how well abemaciclib, which may block enzymes needed for tumor cell growth, works with radiation therapy to shrink tumors before surgical removal. Participants receive abemaciclib orally twice daily for 28 days, repeated for up to three cycles if no disease progression or unacceptable side effects occur. Radiation therapy is given over 28 sessions starting on day 15 of the first cycle. After completing radiation, patients may undergo surgery to remove the tumor. Imaging tests like CT or MRI scans are done during screening and throughout the study. During the study, patients are closely monitored for side effects and treatment response, including scans and lab tests. The main outcome is to determine the recommended dose of abemaciclib with radiation within 28 days. Other outcomes include tumor response rates, surgery success with clear margins, and adverse events. Follow-up occurs 30 days after treatment ends to check safety and recovery.
CONDITIONS
Brief 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...
- Adults 18 years or older
- Newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma confirmed by appropriate testing
- Presence of a dedifferentiated tumor component shown by histology or imaging
- At least one measurable target lesion by RECIST v1.1 via CT or MRI
- Tumor judged to be surgically resectable at enrollment
- Planned neoadjuvant radiation therapy followed by surgery with treatment plan approval
- Adequate blood counts and liver function within specified limits without recent blood transfusion or growth factor support
- Serum albumin 2.8 g/dl or higher
- Serum creatinine within limits or adequate kidney function
- Urine protein/creatinine ratio at or below 1 mg/mg
- ECOG performance status 0 or 1
- Males or non-pregnant, non-breastfeeding females with agreed contraception methods
- Life expectancy greater than 3 months
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures
You will not qualify if you...
- Prior systemic anticancer therapy for this diagnosis
- Prior radiation therapy to the affected area
- Known central nervous system metastases
- Evidence of distant metastatic disease at treatment start
- History of thromboembolic events within 1 year
- History of serious heart rhythm problems or sudden cardiac arrest
- Major surgery within 14 days before enrollment
- Ongoing anticoagulation therapy for thromboembolism
- History of interstitial lung disease
- Serious uncontrolled medical conditions that could prevent study participation
- Pregnant or breastfeeding females
- Inability to swallow tablets
- Allergies to study treatment components
- Diagnosis of another recent malignancy except certain cured tumors
- Use of medications that cannot be stopped and may interact unsafely with abemaciclib
- Recent infection requiring systemic treatment completed within 14 days
- Active systemic bacterial, fungal, or viral infections
- Participation in other incompatible medical research studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including CT or MRI scans
Duration - Up to 3 cycles of 28 days each
Participants receive abemaciclib orally twice daily in cycles of 28 days for up to 3 cycles. Radiation therapy is delivered over 28 fractions starting on day 15 of the first cycle. Treatment continues in the absence of disease progression or unacceptable toxicity.
Daily medication with radiation therapy sessions over approximately 5.5 weeks
Duration - Variable, following completion of radiation therapy
After completing radiation therapy, participants may undergo surgery to remove the tumor.
1 surgical procedure visit
Duration - 30 days
Participants are followed up 30 days after completing study treatment to monitor safety and recovery.
1 follow-up visit (in-person)
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
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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