A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Abemaciclib
DrugGiven PO
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Radiation Therapy
RadiationUndergo radiation therapy
Therapeutic Surgical Procedure
Procedure/SurgeryUndergo surgery
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Treatment (abemaciclib, radiation therapy, surgery)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Recommended phase 2 dose of abemaciclib in combination with radiation
Time frame
Up to 28 daysSecondary outcomes
1
Rate of pathologic response
Time frame
Up to 2 years2
Rate of surgical excision with negative margins
Time frame
Up to 2 years3
Incidence of adverse events
Will be assessed by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame
Up to 30 days post treatment4
Rate of discontinuation of abemaciclib monotherapy
Time frame
Within the first 15 days (+7 days) of Cycle 1 Day 1 (Cycle is 28 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov