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NCT02168777 · ClinicalTrials.gov registry record · Phase 1
Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02168777: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT02168777 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02168777, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib through a dose escalation study, all tumor types that meet certain inclusion/exclusion criteria can be entered. After the recommended dose is determined, the Phase II portion of the study will evaluate tolerability and efficacy of the combination treatment in patients with breast cancer, lung cancer, or colorectal cancer, respectively.
Primary Outcome
Maximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Interventions
- DRUG Refametinib (BAY86-9766)
- DRUG Regorafenib (Stivarga, BAY73-4506)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-06-23 |
| Est. Completion | 2016-04-05 |
| Phase | Phase 1 |
Why NCT02168777 stopped before completion
NCT02168777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Refametinib (BAY86-9766) is the first listed.
NCT02168777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02168777 about?
NCT02168777 is a clinical study titled "Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer". Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib through a dose escalation study, all tumor types that meet certain inclusion/exclusion criteria can be entered. After the recommended dose is determined, the Phase II portion of the study will evaluate tole...
What is the current status of trial NCT02168777?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-06-23. Estimated completion is 2016-04-05.
What interventions are being tested in trial NCT02168777?
The interventions under investigation include: Refametinib (BAY86-9766) (DRUG), Regorafenib (Stivarga, BAY73-4506) (DRUG).
Who is sponsoring clinical trial NCT02168777?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02168777's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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