drugset / Trial / NCT01715142

Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer

NCT01715142

Phase 0 Completed 23 enrolled Jean-Luc Van Laethem Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment

Summary

Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal disease with conventional treatments having little impact on disease course. Novel approaches are urgently needed to address inherent resistance to the current therapies and to identify new drugs or combinations that will have a high chance of success in pancreatic cancer patients. This proof-of-concept trial is studying the "dynamic" tumor response after the administration of a short course of gemcitabine and nab-paclitaxel (Abraxane) (a) during a window interval (4 weeks= 1 cycle) before surgery in resectable pancreatic cancer (cohort 1 = 21 patients) and (b) during at least 8 weeks (2 cycles) in locally advanced or metastatic pancreatic cancer (cohort 2 = 10 patients).

Timeline

Start
2013-03-21
Primary completion
2015-09-21
Completion
2017-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous