Using Abemaciclib and Radiation Therapy Before Surgery for High-Risk Retroperitoneal Sarcoma
Official title: A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for High-Risk Adipocytic Retroperitoneal Sarcomas
Run by University of Washington · NCT06025747 · Data updated 2026-11-12
This study is testing if taking a medication called abemaciclib along with radiation therapy before surgery can help shrink tumors in patients with high-risk retroperitoneal sarcoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | March 19, 2025 |
| Main results expected | August 3, 2027 |
| Study ends | March 3, 2028 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT06025747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma that is surgically resectable.
✕Probably not a fit
Patients with non-resectable tumors or those without the specific genetic markers for this type of sarcoma may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase I trial evaluates the safety and effectiveness of abemaciclib combined with radiation therapy prior to surgery in patients with high-risk adipocytic retroperitoneal sarcoma. Patients will take abemaciclib orally twice daily for 28 days while undergoing radiation therapy. The goal is to shrink tumors and assess the best dosage and side effects of the treatment. Following the treatment, patients will undergo surgery to remove the tumors and will be monitored for 30 days post-treatment.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce tumor size in patients with high-risk retroperitoneal sarcoma.
How similar studies have gone: While this approach is novel in the context of combining abemaciclib with radiation therapy for this specific cancer type, similar strategies have shown promise in other cancers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 * At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable * Have plans to undergo neoadjuvant radiation therapy followed by surgical resection. Review and approval of final treatment plans for subjects receiving radiotherapy locally/at an outside institution must be reviewed and approved by a radiation oncologist investigator prior to initiation of radiotherapy * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (\>= 1.5 GI/L) without granulocyte colony-stimulating factor support in the last 14 days (subjects may not have received blood product transfusion or granulocyte colony-stimulating factor \[G-CSF\] within 14 days prior to screening) * White blood cell count \>= 2500/mm\^3 (\>= 2.5 GI/L) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * Platelets \>= 100,000/mm\^3 (\>= 100 GI/L) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * Hemoglobin \>= 8 g/dL (\>= 80 g/L) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (subjects with Gilbert's disease =\< 2 x ULN and direct bilirubin within normal limits are permitted) (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * Serum albumin \>= 2.8 g/dl (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * Serum creatinine =\< 2.0 x ULN or calculated creatinine clearance \>= 30 mL/min (\>= 0.5 mL/sec) using the Cockcroft-Gault equation (subjects may not have received blood product transfusion or G-CSF within 14 days prior to screening) * 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) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Male or non-pregnant and non-breast feeding female: * Women of child-bearing potential (WOCBP) must agree to use highly effective contraception without interruption from initiation of therapy and continue until 4 months (120 days) after last dose of study therapy. WOCBP must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[hCG\]) result at screening and agree to ongoing pregnancy testing during the study, and at the end of study treatment. A highly effective method of contraception is defined as one that results in a low failure rate (that is, \< 1% per year), when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, or a vasectomized partner * Male subjects must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study * Life expectancy of \> 3 months, as determined by the investigator * Ability to understand and sign informed consent * Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures Exclusion Criteria: * Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) for the investigational diagnosis * Receipt of any prior radiation therapy for any reason to the affected area * Known central nervous system (CNS) metastases * Evidence of distant metastatic disease at time of treatment initiation * History of thromboembolic event within 1 year of treatment initiation. Thromboembolic events include, but are not limited to, deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis * History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest * History of any major surgery within 14 days prior to enrollment * Receipt of ongoing anti-coagulation for treatment or prophylaxis of thromboembolic event in the setting of prior thromboembolic event * History of interstitial lung disease * Subjects with serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \< 30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea) * Pregnant or lactating females * Inability to swallow tablets * Previously identified allergy or hypersensitivity to components of the study treatment formulations * Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized tumors deemed cured and not treated with systemic therapy * Concurrent use of medications (especially those interacting with CYP3A) that potentially interact unsafely with abemaciclib which cannot be discontinued or substituted * Recent infection requiring systemic anti-infective treatment that was completed =\< 14 days prior to enrollment (except for uncomplicated urinary tract infection or upper respiratory tract infection). Any active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening for human immunodeficiency virus (HIV)/hepatitis is not required for enrollment * Concurrent enrollment in any other type of medical research (for example: medical device) judged by the investigator not to be scientifically or medically compatible with this study
Where it's running
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Jeremy Sharib, MD — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: David Siu
- Email: dsiu@fredhutch.org
- Phone: 206-606-2465
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.