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Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Jan 27, 2025
    • Site details revised at 3 of 3 sites
    v3
  3. Start date: Dec 2024 to Jan 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas. The names of the study drugs and biological agents involved in this study are: * PEEL-224 (a type of Topoisomerase 1 inhibitor) * Vincristine (A type of vinca alkaloid) * Temozolomide (A type of alkylating agent) * Pegfilgrastim or Filgrastim (types of Myeloid growth factors)
Trial Details
NCT Number NCT06709495
Lead Sponsor David S Shulman, MD
Collaborators: Peel Therapeutics Inc
Conditions
(from sponsor)		 Sarcoma, Sarcoma, Ewing, Desmoplastic Small Round Cell Tumor, Refractory Sarcoma, Osteosarcoma, Rhabdomyosarcoma
Related terms Desmoplastic Small Round Cell Tumor, Osteosarcoma, Rhabdomyosarcoma, Sarcoma, Sarcoma, Ewing
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov