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Cyclin-Dependent Kinase (CDK) Inhibitor

Pre-Surgery Abemaciclib + Radiation for Retroperitoneal Sarcoma

Phase 1
Waitlist Available
Led By Lee Cranmer
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Urine protein/creatinine ratio (UPCR) =< 1 mg/mg (=< 113.2 mg/mmol) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening)
Subjects, >= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence in situ hybridization (FISH), or other clinically appropriate methodology in the opinion of the reviewing pathologist. Histologic or imaging evidence of the presence of a dedifferentiated component must be present
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests abemaciclib and radiation therapy before surgery to see if it can shrink tumors in patients with sarcoma. It may stop cell growth and use radiation to kill tumor cells.

Who is the study for?
Adults with newly diagnosed or recurrent high-risk adipocytic retroperitoneal sarcoma that can be removed by surgery. Participants must have good liver and kidney function, stable blood counts, no recent major surgeries or serious infections, and not be pregnant or breastfeeding. They should agree to use effective contraception and have a life expectancy of more than 3 months.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of abemaciclib combined with radiation therapy before surgery in patients with high-risk sarcoma. Abemaciclib is designed to stop tumor growth by blocking certain enzymes needed for cell growth, while radiation aims to kill tumor cells.See study design
What are the potential side effects?
Potential side effects include reactions related to enzyme inhibition which may affect cell growth elsewhere in the body, typical risks associated with radiation such as skin irritation or fatigue, and general surgical risks post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function test for protein is normal and I haven't had blood transfusions or certain injections in the last 2 weeks.
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I am 18 or older with a specific type of sarcoma confirmed by a special test.
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My cancer can be measured by scans according to specific criteria.
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My doctors believe my tumor can be removed with surgery.
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My white blood cell count is healthy without needing medication in the past 2 weeks.
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My hemoglobin level is at least 8 g/dL and I haven't had blood transfusions or G-CSF in the last 14 days.
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My liver enzymes are within normal limits and I haven't had blood transfusions or certain treatments in the last 2 weeks.
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My bilirubin levels are within the normal range, and I haven't had blood transfusions or G-CSF in the last 14 days.
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My blood protein level is at least 2.8 g/dl and I haven't had a blood transfusion or certain injections in the last 2 weeks.
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I am a man or a woman not pregnant or breastfeeding.
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I am using or agree to use effective birth control and will take pregnancy tests as required.
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I will not have unprotected sex with a pregnant woman or a woman who could become pregnant while in the study.
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I am willing and able to follow the study's schedule and procedures.
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My white blood cell count is healthy and I haven't had certain blood treatments in the last 2 weeks.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My platelet count is at least 100,000 and I haven't had blood transfusions or G-CSF shots in the last 14 days.
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My kidney function is within the required range and I haven't had blood transfusions or certain treatments in the last 14 days.
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I am scheduled for radiation therapy before surgery, approved by a radiation oncologist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase 2 dose of abemaciclib in combination with radiation
Secondary outcome measures
Incidence of adverse events
Rate of discontinuation of abemaciclib monotherapy
Rate of pathologic response
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (abemaciclib, radiation therapy, surgery)Experimental Treatment5 Interventions
Prior to surgery, patients receive abemaciclib orally PO 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 CT or MRI during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,734 Previous Clinical Trials
1,842,587 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,610 Previous Clinical Trials
3,200,415 Total Patients Enrolled
Lee CranmerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of abemaciclib, radiation therapy, and surgery been given sanction by the FDA?

"The assessment of safety for this intervention (abemaciclib, radiation therapy, surgery) is estimated at 1 due to a dearth of evidence from Phase 1 trials about its efficacy and protection against harm."

Answered by AI

Are new applicants currently being considered for this clinical trial?

"As per information on clinicaltrials.gov, this research study is no longer seeking participants; the original post was made January 1st 2024 and last revised September 5th 2023. Despite that, 449 other trials are currently recruiting patients."

Answered by AI
~12 spots leftby Mar 2025