Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
Research type
Research Study
Full title
A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
IRAS ID
72314
Contact name
Satvinder Mudan ?? UK Coordinating Investigator
Sponsor organisation
Immodulon Therapeutics Limited
Eudract number
2010-022757-42
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This is a multi-centre, open-label Phase II study in subjects with advanced pancreatic cancer. Patients (male/female, aged <span style="text-decoration:underline;">>18 years) will be eligible if they have proven inoperable ductal adenocarcinoma of the pancreas including locally advanced and metastatic disease (stage III/IV). Other eligibility criteria include no previous chemotherapy, radiotherapy (within the preceding 6 weeks), no other investigational drug treatment (within 3 months) prior to screening; WHO performance status of 0-2; adequate bone marrow, liver, and renal functions. Once eligibility is confirmed, patients will be randomised (2:1) to receive either: Chemotherapy (GEM) with IMM-101 (active group), or Chemotherapy (GEM) alone (control group). The maximum duration of patient participation if assigned to the active group will be approximately 54 weeks (comprising of a 4-week screening period; a 2-week period between first dose of IMM-101 and chemotherapy; followed by up to 12 cycles of GEM plus IMM-101). Control group approximately 52 weeks (comprising of a 4-week screening period followed by up to 12 cycles of GEM). At the end of the 12-cycle treatment phase, all patients will be offered the opportunity to enter a long-term follow-up trial (under a separate protocol) where all patients will receive IMM-101.The safety and tolerability of GEM in combination with IMM-101 to GEM alone will be assessed. Exploratory endpoints include: Clinical signs, symptoms of disease and variation from baseline of selected markers of tumor burden and immunological status. It is planned to randomise sufficient patients to achieve approximately 53 evaluable patients in the active group and 27 evaluable patients in the control group. A patient will be considered to be evaluable if the patient completes at least the first 3 cycles of GEM during the treatment phase of the study and has received at least 6 doses of IMM-101 (if in the active group).
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
11/NE/0083
Date of REC Opinion
17 May 2011
REC opinion
Further Information Favourable Opinion