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A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors

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Trial Profile

A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses of Capecitabine Administered Orally to Patients With Advanced, Refractory Gastrointestinal Tract Tumors

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 14 Jun 2024

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At a glance

  • Drugs Capecitabine (Primary) ; Eniluracil (Primary)
  • Indications Gastrointestinal cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Processa Pharmaceuticals

    • Most Recent Events

    • 11 Jun 2024 According to a Processa Pharmaceuticals media release, from this Phase 1b trial, we have been able to define the MTD and the RP2DR to use in our Phase 2 Optimal Dosage Regimen trial in breast cancer in the third quarter of 2024.
    • 11 Jun 2024 Results presented in a Processa Pharmaceuticals Media Release.
    • 10 Jun 2024 Planned End Date changed from 10 Mar 2024 to 10 Aug 2024.

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