A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
No clinically relevant deleterious effect of IMM-101 on safety and tolerability.
A clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles will be judged by: Local and systemic toxicities. Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0. QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire).Efficacy will be defined as a clinically relevant improvement in one or more markers of disease status.
After 12 months or as clinically indicated
Angus Dalgleish, Professor
St George's, University of London
Italy: Ministry of Health