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Cyclin-Dependent Kinase (CDK) Inhibitor

Pre-Surgery Abemaciclib + Radiation for Retroperitoneal Sarcoma

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

<p>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.</p>

Q: Are new applicants currently being considered for this clinical trial?

<p>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.</p>

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 must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), assessed via CT scan or MRI

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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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 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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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 fully active or restricted in physically strenuous activity but can do light work.

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I am scheduled for radiation therapy before surgery, approved by a radiation oncologist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,739 Previous Clinical Trials

1,847,910 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,617 Previous Clinical Trials

3,201,182 Total Patients Enrolled

Lee CranmerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

3 Previous Clinical Trials

60 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

Recent research and studies

clinicaltrials.govStudy

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

2024. "Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06025747.