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Clinical trialNCT02102022TerminatedPhase 1/PHASE2Interventional

Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma

SponsorPolaris GroupEnrollment140Advanced Gastrointestinal (GI) MalignanciesColorectal CancerGastric CancerHepatocellular Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Phase 1: Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies. Phase 2: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

35 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

China
  • the Chinese People'S Liberation Army 81 Hospital

    Nanjing, Jiangsu, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, China

Italy
  • Irccs Ca Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, Italy

  • National Cancer Institute of Napoli Irccs G. Pascale

    Naples, Italy

South Korea
  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

  • Pusan National University Hospital

    Busan, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • the Catholic University of Korea, Seoul St. Mary'S Hospital

    Seoul, South Korea

Taiwan
  • Changhua Christian Hospital

    Changhua, Taiwan

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohsiung City, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, Taiwan

  • Chi Mei Medical Center

    Tainan, Taiwan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Mackay Memorial Hospital

    Taipei, Taiwan

  • Taipei Medical University Hospital

    Taipei, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tri-Service General Hospital

    Taipei, Taiwan

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, Taiwan

United Kingdom
  • the Clatterbridge Cancer Centre Nhs Foundation Trust

    Bebington, Wirral, United Kingdom

  • Guy'S & St Thomas' Nhs Foundation Trust

    London, United Kingdom

  • Royal Free Hospital

    London, United Kingdom

  • the Christie Nhs Foundation Trust

    Manchester, United Kingdom

United States
  • California Pacific Medical Center

    San Francisco, California, United States

  • Emory University

    Atlanta, Georgia, United States

  • the University of Chicago Medical Center

    Chicago, Illinois, United States

  • the University of Kansas Cancer Center

    Westwood, Kansas, United States

  • Masonic Cancer Center

    Minneapolis, Minnesota, United States

  • Washington University

    St Louis, Missouri, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, United States

  • Oregon Health and Science University

    Portland, Oregon, United States

  • Upmc Hillman Cancer Center

    Pittsburgh, Pennsylvania, United States

  • University of Washington

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ADI-PEG 20 plus modified FOLFOX6
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2014
Primary completion
29 Feb 2020
Completion
29 Feb 2020
Last update posted
25 Apr 2022
Registered enrollment
140
Registry id
NCT02102022

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.