Trial · NCT02168777

Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer

NCT02168777, Phase 1, Terminated, Bayer; results first posted 2018-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer. Trials, record NCT02168777. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02168777

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer
NCT number: NCT02168777
Status: Terminated
Phases: Phase 1
Enrollment: 20 participants, actual
Lead sponsor: Bayer
Conditions: Neoplasms
Interventions: Refametinib (BAY86-9766), Regorafenib (Stivarga, BAY73-4506)
First posted: 2014-06-20
Last updated: 2018-01-26
Other registries' IDs: eudract:2013-004861-15
Results first posted: 2018-01-26
Limitations and caveats: The sponsor decided not to conduct the Phase 2 part of the study due to strategic portfolio re-prioritization.

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	Maximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	Maximum drug concentration in plasma after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib Metabolite M-11	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	Maximum drug concentration in plasma after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-2	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-5	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-2	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Primary	Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-5	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	Pharmacokinetic (PK) analysis set for multiple dose.	μg/L	GEOMETRIC_MEAN
PRIMARY	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	PK analysis set for multiple dose.	μg/L	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	PK analysis set for multiple dose.	μg*h/L	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib Metabolite M-11	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose	PK analysis set for multiple dose.	μg*h/L	GEOMETRIC_MEAN
PRIMARY	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	PK analysis set for multiple dose.	μg/L	GEOMETRIC_MEAN
PRIMARY	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-2	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	PK analysis set for multiple dose.	μg/L	GEOMETRIC_MEAN
PRIMARY	Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-5	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	PK analysis set for multiple dose.	μg/L	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	PK analysis set for multiple dose.	μg*h/L	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-2	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	PK analysis set for multiple dose.	μg*h/L	GEOMETRIC_MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-5	Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose	PK analysis set for multiple dose.	μg*h/L	GEOMETRIC_MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group97

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib	Ph1b-Refametinib/Regorafenib Cohort 0	NA	Geometric Coefficient of Variation NA	μg/L
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib	Ph1b-Refametinib/Regorafenib Cohort -1	315.9	Geometric Coefficient of Variation 43	μg/L
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib	Ph1b-Refametinib/Regorafenib Cohort -1a	390.7	Geometric Coefficient of Variation 52	μg/L
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11	Ph1b-Refametinib/Regorafenib Cohort 0	NA	Geometric Coefficient of Variation NA	μg/L
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11	Ph1b-Refametinib/Regorafenib Cohort -1	104.9	Geometric Coefficient of Variation 36	μg/L
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11	Ph1b-Refametinib/Regorafenib Cohort -1a	112.3	Geometric Coefficient of Variation 44	μg/L
Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib	Ph1b-Refametinib/Regorafenib Cohort 0	NA	Geometric Coefficient of Variation NA	μg*h/L
Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib	Ph1b-Refametinib/Regorafenib Cohort -1	2399.2	Geometric Coefficient of Variation 65	μg*h/L
Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib	Ph1b-Refametinib/Regorafenib Cohort -1a	3632.3	Geometric Coefficient of Variation 51	μg*h/L
Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib Metabolite M-11	Ph1b-Refametinib/Regorafenib Cohort 0	NA	Geometric Coefficient of Variation NA	μg*h/L

1 to 10 of 97Source ClinicalTrials.gov

See all 97 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ph1b-Refametinib/Regorafenib Cohort 0	2
Overall Study	STARTED	Ph1b-Refametinib/Regorafenib Cohort -1	7
Overall Study	STARTED	Ph1b-Refametinib/Regorafenib Cohort -1a	11
Overall Study	COMPLETED	Ph1b-Refametinib/Regorafenib Cohort 0	0
Overall Study	COMPLETED	Ph1b-Refametinib/Regorafenib Cohort -1	0
Overall Study	COMPLETED	Ph1b-Refametinib/Regorafenib Cohort -1a	0
Overall Study	NOT COMPLETED	Ph1b-Refametinib/Regorafenib Cohort 0	2
Overall Study	NOT COMPLETED	Ph1b-Refametinib/Regorafenib Cohort -1	7
Overall Study	NOT COMPLETED	Ph1b-Refametinib/Regorafenib Cohort -1a	11

Source ClinicalTrials.gov

Adverse events408

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort 0	1	2	3
other	Anaemia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort -1	3	7	7
other	Anaemia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort -1a	4	11	7
other	Leukocytosis	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort 0	0	2	0
other	Leukocytosis	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort -1	1	7	1
other	Leukocytosis	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort -1a	0	11	0
other	Leukopenia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort 0	1	2	1
other	Leukopenia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort -1	0	7	0
other	Leukopenia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort -1a	0	11	0
other	Lymphopenia	Blood and lymphatic system disorders	Ph1b - Refametinib/Regorafenib Cohort 0	1	2	2

1 to 10 of 408Source ClinicalTrials.gov

See all 408 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ph1b - Refametinib/Regorafenib Cohort 0
Total, all-cause mortality	Ph1b - Refametinib/Regorafenib Cohort -1
Total, all-cause mortality	Ph1b - Refametinib/Regorafenib Cohort -1a
Total, other adverse events	Ph1b - Refametinib/Regorafenib Cohort 0	2	2
Total, other adverse events	Ph1b - Refametinib/Regorafenib Cohort -1	7	7
Total, other adverse events	Ph1b - Refametinib/Regorafenib Cohort -1a	11	11
Total, serious adverse events	Ph1b - Refametinib/Regorafenib Cohort 0	0	2
Total, serious adverse events	Ph1b - Refametinib/Regorafenib Cohort -1	4	7
Total, serious adverse events	Ph1b - Refametinib/Regorafenib Cohort -1a	5	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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