Spots Global Cancer Trial Database for Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma
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Trial Identification
Brief Title: Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma
Official Title: Phase 1/2 Study of ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma
Study ID: NCT02102022
Interventions
Study Description
Brief Summary: 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).
Detailed Description: Phase 1:The primary objective of the dose escalation portion of this study was to assess the safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin (mFOLFOX6) in advanced GI malignancies. The primary objective of the maximum tolerated dose (MTD) expansion phase (recommended phase 2 dose \[RP2D\]) of this study was to determine preliminary estimates of efficacy, measured by RECIST 1.1 criteria, for ADI-PEG 20 in combination with FOLFOX in hepatocellular carcinoma (HCC), gastro-esophageal cancer (GEC), and colorectal cancer (CRC). Phase 2: The primary objective of this single arm trial is ORR. Based on a two-sided exact test of a one-sample proportion with an alpha of 0.05, under a presumed ORR of 22%, there is 80% power to yield 95% confidence interval of 15-26%, which will require 46 objective responses in 225 subjects. A futility analysis will be described in the Statistical Analysis Plan.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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
The Chinese People's Liberation Army 81 Hospital, Nanjing, Jiangsu, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, Lombardia, Italy
National Cancer Institute of Napoli IRCCS G. Pascale, Napoli, , Italy
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul, , Korea, Republic of
Changhua Christian Hospital, Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Chang Gung Medical Foundation - Kaohsiung, Kaohsiung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Medical Center, Tainan, , Taiwan
Chi Mei Hospital, Liouying, 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
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, United Kingdom
Royal Free Hospital, London, , United Kingdom
Guy's & St Thomas' NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: James Harding, MD
Affiliation: Memorial Sloan-Kettering Cancer Center (MSKCC)
Role: PRINCIPAL_INVESTIGATOR
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