Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by EpicentRx. The registered enrollment target is 62 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02096354
The ClinicalTrials.gov registry entry for NCT02096354 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 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 3 interventions - of which Regorafenib is the first listed.
NCT02096354 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.