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Phase 1/2 Study of ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma

Trial Profile

Phase 1/2 Study of ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Oct 2019

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At a glance

  • Drugs Pegargiminase (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Carcinoma; Gastrointestinal cancer; Liver cancer
  • Focus Therapeutic Use
  • Sponsors Polaris Pharmaceuticals
  • Most Recent Events

    • 17 May 2019 Planned End Date changed from 1 Oct 2019 to 1 Oct 2020.
    • 17 May 2019 Planned primary completion date changed from 1 Aug 2019 to 1 Aug 2020.
    • 19 Jan 2019 Futility will be assessed three times during the study based on having ORR data available for 56, 110, and 166 patients. This Phase 2 will be stopped for futility if the conditional power drops below 20% at any of these time points as per trial design presented at the 2019 Gastrointestinal Cancers Symposium
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