ASC-201 Plus TAS-102 in Advanced Gastric Cancer
Research type
Research Study
Full title
A Randomized, Double-blind Study to Investigate the Safety, Pharmacokinetics, and Antitumor Activity of ASC-201 Plus Trifluridine/Tipiracil Compared With Trifluridine/Tipiracil in Patients With Advanced Gastric Cancer in a Third Line Treatment Setting After an Initial Dose Escalation Phase
IRAS ID
305899
Contact name
Wasat Mansoor
Contact email
Sponsor organisation
Ascelia Pharma AB
Eudract number
2021-003799-15
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
This clinical research study is testing an investigational drug, called ASC-201, in combination with standard treatment (tifluridine/tipiracil) for people with advanced stomach cancer. ASC-201 contains an active substance, irinotecan, that prevents cancer cells from growing and dividing. Irinotecan is currently approved for intravenous (IV) use for the treatment of multiple types of cancer. ASC-201 is designed to be taken by mouth, with the standard treatment and it is hoped that this form of the drug will be easier for patients to take whilst still delays cancer progression. There are 2 phases; Phase 1 is an open-label study that will find the safe dose of ASC-201 to use with standard treatment; Phase 2 is a double-blind study, so that neither the patient or the study doctor will know if you receive ASC-201 or placebo. Phase 2 will look if the ASC-201 works in patients with advanced stomach cancer and delays cancer progression. The study is split into 3 periods, a screening period, treatment period and follow-up period and will last up to 3 years. Patients will undergo physical exams, vital signs, blood/urine sampling, tumour scans, heart examinations and other assessments. Around 139 people at 31 centres (UK; US; Spain) will take part in this study.
REC name
Wales REC 5
REC reference
22/WA/0048
Date of REC Opinion
25 Mar 2022
REC opinion
Further Information Favourable Opinion