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NCT02096354 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by EpicentRx.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT02096354: Completed Phase 2 study, sponsored by EpicentRx.
NCT02096354 is a Phase 2 study that has completed, run by EpicentRx. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02096354, a Phase 2 study, has completed, sponsored by EpicentRx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study. Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to participate in this study. There will be two groups of patients (Randomized, open label study), one of these will receive RRx-001 and the other one will receive regorafenib. If patients qualify to participate in this study, they will be randomly assigned to the 'interventional arm' where patients will receive the experimental drug, RRx-001, or the 'control arm' where they will receive the current standard-of-care, Regorafenib. Patients have a 66% chance (2 out of 3) of receiving RRx-001 and a 33 % chance (1 out of 3) of receiving regorafenib. On progression in the first part of the study, provided ECOG performance status is adequate, and if clinically appropriate i.e. there are no absolute or relative contraindications in the opinion of the Investigator, all subjects will enter the second part of the study and receive irinotecan plus bevacizumab. Whether patients are given RRx-001 or regorafenib, they will also receive best supportive care, which includes treatments to help manage side effects and symptoms of cancer. This is an open label study, which means patients will know to which of these treatments, RRx-001 or regorafenib, they are assigned.
Primary Outcome
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 47 months
Interventions
- DRUG Regorafenib
- DRUG Irinotecan
- DRUG RRx-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2014-05 |
| Est. Completion | 2020-10-08 |
| Phase | Phase 2 |
What the finished NCT02096354 record still lists
NCT02096354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Regorafenib is the first listed.
NCT02096354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02096354 about?
NCT02096354 is a clinical study titled "A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer". This two-stage study is designed to compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies in a parallel comparative study. Patients who are suffering from advanced or metastatic (meaning the disease has spread) colorectal cancer are invited to pa...
What is the current status of trial NCT02096354?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2014-05. Estimated completion is 2020-10-08.
What interventions are being tested in trial NCT02096354?
The interventions under investigation include: Regorafenib (DRUG), Irinotecan (DRUG), RRx-001 (DRUG).
Who is sponsoring clinical trial NCT02096354?
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 NCT02096354's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 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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