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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: Clinical Trial Phase 2 study, sponsored by EpicentRx.
NCT02452970 is a Phase 2 study that was terminated before completion, run by EpicentRx. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall objective response (RECIST)
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 |
Why NCT02452970 stopped before completion
NCT02452970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which RRx-001 is the first listed.
NCT02452970 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02452970's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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