RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/7/2018 |
| Start Date: | July 16, 2015 |
| End Date: | December 2018 |
A Phase 2, Single-Arm, Open-label, Study of RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
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.
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.
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of biliary tract
adenocarcinoma/cholangiocarcinoma
- Must have locally advanced or distant metastatic disease that is not surgically
curable
- Failed first-line chemotherapy
- Age ≥ 18 years
- Life expectancy of at least 12 weeks (3 months)
- Performance status 0 or 1
- Adequate liver, kidney, and bone marrow function
Exclusion Criteria:
- Symptomatic metastatic brain or meningeal tumors
- Investigational compound within 4 weeks of enrollment
- History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for
reasons other than progression (i.e. toxicity)
- Any medical condition which, in the investigator's opinion, makes the patient
unsuitable for participation
- Pregnant or nursing
- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results
- Albumin <2.8
- Uncontrolled or clinically relevant ascites
- Absolute contraindication for MRI imaging such as intracorporeal metal or pacemaker
We found this trial at
1
site
Baltimore, Maryland 21231
Principal Investigator: Ana De Jesus Acosta, MD
Phone: 410-955-4035
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