A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas

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.

Trial Details

NCT ID
NCT06025747
Phase
PHASE1
Sponsor
University of Washington
Status
RECRUITING
Cancer Type
Liposarcoma Sarcoma
Interventions
  • Abemaciclib
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Radiation Therapy
  • Therapeutic Surgical Procedure
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Subjects, \>= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence …
  • 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…
  • 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 recei…

For full eligibility, visit ClinicalTrials.gov.

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