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NCT01973868 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01973868: Completed Phase 1 study, sponsored by Bayer.
NCT01973868 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01973868, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Primary Outcome
MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 20 %, or as the maximum dose administered, whichever is achieved first during dose escalation
Interventions
- DRUG Regorafenib (Stivarga, BAY73-4506)
- DRUG Cetuximab (ERBITUX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-11-21 |
| Est. Completion | 2018-04-03 |
| Phase | Phase 1 |
What the finished NCT01973868 record still lists
NCT01973868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Regorafenib (Stivarga, BAY73-4506) is the first listed.
NCT01973868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01973868 about?
NCT01973868 is a clinical study titled "Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination". To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
What is the current status of trial NCT01973868?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-11-21. Estimated completion is 2018-04-03.
What interventions are being tested in trial NCT01973868?
The interventions under investigation include: Regorafenib (Stivarga, BAY73-4506) (DRUG), Cetuximab (ERBITUX) (DRUG).
Who is sponsoring clinical trial NCT01973868?
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 NCT01973868's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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