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A Phase 1b, Open-label, Dose-escalation Clinical Study Evaluating the Safety of Camsirubicin With Prophylactic Pegfilgrastim in the Treatment of Advanced Soft Tissue Sarcomas

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Trial Profile

A Phase 1b, Open-label, Dose-escalation Clinical Study Evaluating the Safety of Camsirubicin With Prophylactic Pegfilgrastim in the Treatment of Advanced Soft Tissue Sarcomas

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 21 May 2024

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At a glance

  • Drugs Camsirubicin (Primary) ; Pegfilgrastim (Primary)
  • Indications Leiomyosarcoma; Lipoma; Liposarcoma; Malignant fibrous histiocytoma; Myxoid liposarcoma; Sarcoma; Soft tissue sarcoma; Synovial sarcoma
  • Focus Adverse reactions

    • Most Recent Events

    • 13 May 2024 Status changed from recruiting to discontinued.
    • 28 Mar 2024 According to a Monopar Therapeutics media release, company is presently enrolling patients at the fifth dose level, which is over twice the highest dose reached in any prior camsirubicin clinical trial (650 mg/m2 versus 265 mg/m2).
    • 22 Feb 2024 Planned primary completion date changed from 1 Jun 2023 to 1 Jun 2025.

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