drugset / Trial / NCT02921737

TAS-102 (Lonsurf) in Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Post First Line Chemotherapy (UF-STO-PANC-003)

NCT02921737

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to evaluate the activity of TAS-102 in previously treated metastatic and locally advanced unresectable pancreatic cancer after progression through or intolerance to first or second line chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is to determine the progression free survival (PFS) in subjects with unresectable pancreatic adenocarcinoma.

Timeline

Start
2017-11-09
Primary completion
2020-07-26
Completion
2020-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject TAS-102 Small molecule 35 mg/m2 Oral