RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
Status:
Terminated
Trial end date:
2016-05-25
Target enrollment:
Participant gender:
Summary
The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic
agent, which turns on a number of beneficial genes that the tumor has silenced, can
resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and
cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label
study, which means that patients will know what treatments they are receiving, is EPIC, a
hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and
Cholangiocarcinoma.
The study treatment is divided into two stages. During the first stage, patients will receive
RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At
that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as
long as the tumors respond to them to determine whether resensitization has occurred.
The primary objective of this clinical trial is to evaluate the progression-free survival
(PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.