drugset / Trial / NCT02847000

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer

NCT02847000

Phase 0 Completed 13 enrolled Yogen Saunthararajah
NaSingle-groupOpen-labelTreatment

Summary

Patients with pancreatic cancer which has stopped responding to one or more chemotherapy drugs are asked to take part in this study. The study hopes to find out whether decitabine, the drug being studied, will have an effect on pancreatic cancer. The decitabine is being given at a lower dose than its approved use. It is also being given with another drug, tetrahydrouridine (THU), to improve the exposure of your pancreatic cancer cells to decitabine. The purpose of this study is to determine if the drug combination of decitabine and tetrahydrouridine can recognize a certain DNA target in your cancer. All cells have DNA within them, and tumor cells have abnormal DNA.

Timeline

Start
2016-12-20
Primary completion
2017-10-25
Completion
2017-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 10 mg Oral
Subject Decitabine Small molecule 15 mg Oral
Subject Decitabine Small molecule 20 mg Oral
Background Tetrahydrouridine Small molecule 500 mg Oral
Background Tetrahydrouridine Small molecule 750 mg Oral
Background Tetrahydrouridine Small molecule 1000 mg Oral