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NCT02452970 · ClinicalTrials.gov registry record · Phase 2
RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy
A Phase 2 study, sponsored by EpicentRx.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02452970 is a Phase 2 study that was terminated before completion, run by EpicentRx. The registered enrollment target is 4 participants.
The verdict
NCT02452970, a Phase 2 study, was terminated before completion, sponsored by EpicentRx.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Interventions
- DRUG RRx-001
- DRUG Gemcitabine and cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-07-16 |
| Est. Completion | 2016-05-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02452970
The ClinicalTrials.gov registry entry for NCT02452970 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EpicentRx, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RRx-001 is the first listed.
NCT02452970 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02452970 about?
NCT02452970 is a clinical study titled "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 ...
What is the current status of trial NCT02452970?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2015-07-16. Estimated completion is 2016-05-25.
What interventions are being tested in trial NCT02452970?
The interventions under investigation include: RRx-001 (DRUG), Gemcitabine and cisplatin (DRUG).
Who is sponsoring clinical trial NCT02452970?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
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