Phase 2 study of CO-1.01 in patients with pancreatic adenocarcinoma
Research type
Research Study
Full title
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma.
IRAS ID
47280
Contact name
Thomas Ronald Jeffry Evans
Contact email
Sponsor organisation
Clovis Oncology, Inc.
Eudract number
2009-018240-23
Clinicaltrials.gov Identifier
Research summary
PHASE 2 RANDOMISED, OPEN-LABEL, MULTICENTER STUDY COMPARING CO-1.01 WITH GEMCITABINE IN PATIENTS WITH METASTATIC PANCREATIC CANCERThis study is being conducted to compare the overall survival of patients with metastatic pancreatic cancer and low hENT1 expression treated with CO-1.01 (study drug) and gemcitabine (comparator drug). hENT1 is a protein on the cell surface that transports some drugs into the cell including gemcitabine, but not CO-1.01. It is possible that gemcitabine is less effective than the study drug in patients who have low levels of the hENT1 protein. Therefore the study drug may help patients who have low levels of hENT1 and who get less benefit from gemcitabine.13 countries worldwide are participating in this study including the UK. Approximately 250 patients with pancreatic cancer are planned to participate in this study. In the UK, the study will be conducted by medical oncologists at NHS hospitals in England and Scotland. Participants will be assigned randomly (by chance) to one of the study drugs. Participants assigned to CO-1.01 will receive the drug at a dose of 1250 mg/m2 through a vein, administered over 30 minutes every week for 3 weeks followed by one week of rest (study cycle). Participants randomised to gemcitabine will receive a dose of 1000 mg/m2 through a vein administered over 30 minutes every week for 7 weeks followed by one week of rest (study cycle). After that, they will receive gemcitabine every week for 3 weeks followed by one week of rest.Neither the participants nor the study doctor will be able to choose what study drug the participant will be taking, but they will both know which drug that is. General health and research related blood tests, urine tests, ECGs and scans will be performed in order to assess the participants?? health and the efficacy of the study drug.
REC name
West of Scotland REC 1
REC reference
10/S0703/41
Date of REC Opinion
18 Aug 2010
REC opinion
Further Information Favourable Opinion