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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Jun 2018

At a glance

  • Drugs Pegargiminase (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Colorectal cancer; Gastric cancer; Gastrointestinal cancer; Liver cancer
  • Focus Adverse reactions
  • Sponsors Polaris Pharmaceuticals
  • Most Recent Events

    • 05 Jun 2018 Results (n=27) presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 03 Jun 2018 According to a Polaris Pharmaceuticals media release, based on positive results from phase 1, US FDA permitted to expanded into a global, phase 2, single-arm study to support accelerated approval for HCC patients who have failed at least two lines of prior systemic therapies. This trial will be expanded into UK, Italy, Korea and China.
    • 03 Jun 2018 Results (N=38) presented in a Polaris Pharmaceuticals Media Release.
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