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NCT02368886 · ClinicalTrials.gov registry record · Phase 2
Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Academic and Community Cancer Research United.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT02368886: Completed Phase 2 study, sponsored by Academic and Community Cancer Research United.
NCT02368886 is a Phase 2 study that has completed, run by Academic and Community Cancer Research United. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02368886, a Phase 2 study, has completed, sponsored by Academic and Community Cancer Research United.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid cream that is commonly used to treat a variety of skin conditions and may help prevent hand-foot skin reactions in patients receiving regorafenib.
Primary Outcome
Fisher exact test will be used to detect a difference course 3 between arms (starting low dose \[pooled arm A1 and A2\] versus \[vs.\] standard dose \[pooled arm B1 and B2\]). The proportion of patients who complete 2 courses of protocol treatment and initiate course 3 will be computed by arm with its 95% confidence interval using exact method.
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Regorafenib
- OTHER Pharmacological Study
- DRUG Clobetasol Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2015-03-27 |
| Est. Completion | 2023-03-02 |
| Phase | Phase 2 |
What the finished NCT02368886 record still lists
NCT02368886 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02368886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02368886 about?
NCT02368886 is a clinical study titled "Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer". This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the gr...
What is the current status of trial NCT02368886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2015-03-27. Estimated completion is 2023-03-02.
What interventions are being tested in trial NCT02368886?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Regorafenib (DRUG), Pharmacological Study (OTHER), Clobetasol Propionate (DRUG).
Who is sponsoring clinical trial NCT02368886?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02368886's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 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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