Spots Global Cancer Trial Database for A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
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Trial Identification
Brief Title: A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
Official Title: A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
Study ID: NCT01303172
Conditions
Study Description
Brief Summary: To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.
Detailed Description: Patients in the IMM 101 treated group received an initial dose of IMM-101 followed by a maximum of 12 cycles of Gemcitabine (plus IMM-101); patients in the control group received Gemcitabine alone. All patients were to receive Gemcitabine once weekly for 3 consecutive weeks out of every 4 weeks. Patients in the IMM 101 treated group were to receive IMM 101 every 2 weeks for the first 3 doses, followed by a 4 week rest, then IMM-101 every 2 weeks for the next 3 doses. After this time, patients received doses every 4 weeks. Gemcitabine treatment began at least 14 days after the first dose of IMM-101 in the IMM 101 treated group. Patients who completed the Main Study and who provided informed consent were eligible to participate in a long term treatment Sub-Study. All patients received IMM-101 in the open-label, single arm, Sub-Study irrespective of whether they had been randomised to Gemcitabine or Gemcitabine plus IMM-101 in the main study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cyprus Oncology Centre, Nicosia, Strovolos, Cyprus
Adelaide, Meath & National Childrens Hospital,, Dublin, , Ireland
St Vicents University Hospital, Dublin, , Ireland
Azienda Ospedaliero-Universitaria di Bologna, Bologna, , Italy
A.O. Santa Croce e Carle, Struttura Complessa di Oncologia Medica, Cuneo, , Italy
Azienda Ospedaliera San Gerardo Struttura Complessa Oncologia Medica, Monza, , Italy
AOU Maggiore della Carità, Novara, , Italy
Medical Oncology Department, Central University Hospital of Asturias, Oviedo, Asturias, Spain
Hospital General de Alicante, Alicante, , Spain
Hospital Gregorio Marañon, Madrid, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Department of Medical Oncology, Hospital Universitari La Fe,, Valencia, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Airedale General Hospital, Skipton, West Yorkshire, United Kingdom
Royal Blackburn Hospital, Blackburn, , United Kingdom
Bradford Royal Infirmary, Bradford, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
Ninewells Hospital,, Dundee, , United Kingdom
Mount Vernon Cancer Centre, London, , United Kingdom
The London Clinic Cancer Centre, London, , United Kingdom
Peterbrough City Hospital, Haematology/Oncology Dept,, Peterborough, , United Kingdom
Contact Details
Name: Angus Dalgleish, Professor
Affiliation: St George's, University of London
Role: PRINCIPAL_INVESTIGATOR
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