Trial · NCT01973868
Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
NCT01973868, Phase 1, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination. Trials, record NCT01973868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01973868
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination
- NCT number
- NCT01973868
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 42 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Neoplasms
- Interventions
- Regorafenib (Stivarga, BAY73-4506), Cetuximab (ERBITUX)
- First posted
- 2013-11-01
- Last updated
- 2019-04-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of regorafenib in combination with cetuximab | 1 month | 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 |
| Primary | Number of participants with Adverse Events as a measure of safety and tolerability | Up to 2 years or longer | |
| Primary | Cmax,md (Cmax after multiple dose) for regorafenib and cetuximab | Multiple time points on Day 15 | |
| Primary | AUC(0-24)md (AUC from time zero to 24 hours after multiple-dose administration) for regorafenib | Multiple time points on Day 15 | |
| Primary | AUC(0-26)md (AUC from time zero to 26 hours after multiple-dose administration) for cetuximab | Multiple time points on Day 15 | |
| Secondary | Tumor response according to RECIST 1.1 | Up to 2 years or longer | |
| Secondary | tmax,md (tmax after multiple-dose administration) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and cetuximab | Multiple time points on Day 15 | |
| Secondary | tlast,md (tlast after multiple dosing) for regorafenib, its metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) and cetuximab | Multiple time points on Day 15 | |
| Secondary | Cmax,md for metabolites M-2 (BAY75-7495) and M-5 (BAY81-8752) | Multiple time points on Day 15 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30958892 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01973868
GET https://conductscience.org/api/trials/v1/NCT01973868/registered