110
Participants
Start Date
June 30, 2011
Primary Completion Date
June 30, 2014
Study Completion Date
January 31, 2016
IMM-101
"IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.~A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL) will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.~Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine."
Gemcitabine
"Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks.~Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).~Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol."
Cyprus Oncology Centre, Nicosia
Azienda Ospedaliera San Gerardo Struttura Complessa Oncologia Medica, Monza
Hospital Gregorio Marañon, Madrid
Azienda Ospedaliero-Universitaria di Bologna, Bologna
Instituto Valenciano de Oncologia, Valencia
Department of Medical Oncology, Hospital Universitari La Fe,, Valencia
Hospital Miguel Servet, Zaragoza
Adelaide, Meath & National Childrens Hospital,, Dublin
St Vicents University Hospital, Dublin
A.O. Santa Croce e Carle, Struttura Complessa di Oncologia Medica, Cuneo
AOU Maggiore della Carità, Novara
Medical Oncology Department, Central University Hospital of Asturias, Oviedo
Hospital General de Alicante, Alicante
Airedale General Hospital, Skipton
Royal Blackburn Hospital, Blackburn
Bradford Royal Infirmary, Bradford
Velindre Cancer Centre, Cardiff
Ninewells Hospital,, Dundee
Mount Vernon Cancer Centre, London
The London Clinic Cancer Centre, London
Peterbrough City Hospital, Haematology/Oncology Dept,, Peterborough
Lead Sponsor
Immodulon Therapeutics Ltd
INDUSTRY