Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma

This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) and for which no known cure is available (advanced). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a

Trial Details

NCT ID
NCT05711615
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Liposarcoma Sarcoma
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Miami, Florida, United States|25.77427,-80.19366
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Patients must have histologically confirmed sarcoma that is metastatic or unresectable and for which there is no known curative treatment
  • Dose escalation cohort: Patients must have histologic diagnosis of leiomyosarcoma (LMS) or selected soft tissue sarcomas (myxofibrosarcoma \[MFS\],…
  • Dose expansion cohort: Patients must have histology diagnosis of LMS. Pathology review and confirmation of diagnosis will occur at the site enrolli…
  • Dose escalation cohort: Patients must have evaluable disease that is amenable to biopsy

For full eligibility, visit ClinicalTrials.gov.

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