Protocol of the IntenSify-Trial: An open-label phase I trial of the CYP3A inhibitor cobicistat and the cytostatics gemcitabine and nab-paclitaxel in patients with advanced stage or metastatic pancreatic ductal adenocarcinoma to evaluate the combination's pharmacokinetics, safety, and efficacy.

Intensify-Trial: Investigating a Novel Combination Therapy for Pancreatic Ductal Adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC) is a challenging and aggressive form of cancer, with limited treatment options. This research proposes a phase I dose escalation trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of a novel combination therapy for advanced or metastatic PDAC. The combination therapy includes gemcitabine, nab-paclitaxel, and cobicistat, a CYP3A inhibitor. The study is based on the premise that CYP3A5 protein expression contributes to resistance to paclitaxel in PDAC cells. Inhibition of CYP3A isozymes, as achieved by cobicistat, may enhance the efficacy of paclitaxel. The trial will utilize a classical 3+3 design to explore the safety and pharmacokinetics of the combination therapy across different dose levels of nab-paclitaxel. The study aims to determine the recommended dose for expansion (RDE) and ultimately investigate the potential of this combination therapy in a larger-scale clinical trial.

A Promising Approach to Overcoming Resistance in PDAC Treatment

This research investigates a novel combination therapy that aims to overcome resistance mechanisms in PDAC treatment by inhibiting CYP3A5 protein expression. The study's findings have the potential to improve the efficacy of paclitaxel and lead to more effective treatment strategies for PDAC.

Hope for Patients with Pancreatic Cancer

Like a camel seeking an oasis in the harsh desert, patients with PDAC often face a challenging journey. This research holds promise for developing more effective treatment options, offering hope for improved outcomes and a better quality of life for individuals battling this challenging disease.

Dr.Camel's Conclusion

This study, like a caravan seeking a new route through the desert, explores innovative approaches to treating PDAC. The investigation of a novel combination therapy, including cobicistat, a CYP3A inhibitor, aims to enhance the efficacy of paclitaxel and potentially overcome resistance mechanisms in PDAC cells. This research offers hope for improved outcomes and a brighter future for those battling this challenging disease.