ABC-04
Research type
Research Study
Full title
ABC-04: A phase Ib trial of cisplatin, gemcitabine and selumetinib (AZD6244) in patients with advanced biliary tract cancer
IRAS ID
45397
Contact name
John Bridgewater
Sponsor organisation
University College London
Eudract number
2010-018522-39
Clinicaltrials.gov Identifier
Research summary
Biliary tract cancers are uncommon cancers accounting for 3% of all GI cancers globally. Surgery is the only chance of cure, however most cases are inoperable and the five year survival for all patients is between 5-10%. Cisplatin and gemcitabine has been defined as the standard of care for patients with advanced biliary tract cancer. It is thought that adding selumetinib to CisGem combination may be more effective than chemotherapy alone.This trial aims to evaluate how safe and tolerable selumetinib is when given in combination with CisGem and to establish the recommended dose to take into phase II studies. Patients will be recruited into cohorts of three and will be assessed for Dose Limiting Toxicities (DLTs) during the first cycle of treatment. Depending on the number of patients who experience DLTs, the cohort may be expanded or patient will be enrolled at the next cohort at a lower dose. Patients will receive up to eight cycles of treatment and may continue to receive selumetinib until progression of disease. Patients will be recruited over 3 sites, all in the UK.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
11/SC/0128
Date of REC Opinion
24 May 2011
REC opinion
Further Information Favourable Opinion