Phase 1-2 Study of ADI plus FOLFOX in GI cancer focusing on HCC
Research type
Research Study
Full title
Phase 1-2 Study of ADI-PEG 20 plus FOLFOX in Subjects with Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma
IRAS ID
236848
Contact name
Tim Meyer
Contact email
Sponsor organisation
Polaris Pharmaceuticals, Inc.
Eudract number
2017-004112-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND9420, Investigational New Drug Application
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The study will determine the effectiveness of the study drug, ADI-PEG 20 given in combination with chemotherapy drugs folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX), while also looking at safety and tolerability. FOLFOX has been approved in China for advanced liver cancer (hepatocellular carcinoma, HCC) patients who have not been treated before. The phase 1 portion of the study is closed. Both ADI-PEG 20 and FOLFOX have been well tolerated in HCC patients. In the phase 2 portion, HCC patients with at least 2 prior systemic therapies will be considered. While on treatment, patients will have weekly visits for dosing of ADI-PEG 20 and other routine care. FOLFOX will be dosed every 2 weeks. Some patients may only be on folinic acid and fluorouracil (FOLF) after 4 weeks of treatment if they have adverse events associated with oxaliplatin. Blood collections and CT/MRI scans are at study-specific timepoints. The phase 2 portion is anticipated to last 2 years. The anticipated treatment period 24 weeks with a possible extension for patients with stable disease or better for up to 104 weeks. Currently 30 sites are projected to take part in the study globally, with about 5 in UK and 9 other sites in the EU, as well as 16 sites in the US, China and Taiwan.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0515
Date of REC Opinion
10 Jul 2018
REC opinion
Further Information Favourable Opinion