18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for RefametinibPrimary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
315.9
± 43
Ph1b-Refametinib/Regorafenib Cohort -1a
390.7
± 52
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11Primary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
104.9
± 36
Ph1b-Refametinib/Regorafenib Cohort -1a
112.3
± 44
Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for RefametinibPrimary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
2399.2
± 65
Ph1b-Refametinib/Regorafenib Cohort -1a
3632.3
± 51
Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib Metabolite M-11Primary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
1013.4
± 40
Ph1b-Refametinib/Regorafenib Cohort -1a
1144.7
± 39
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for RegorafenibPrimary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
1966.0
± 17
Ph1b-Refametinib/Regorafenib Cohort -1a
2206.4
± 34
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-2Primary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
1409.1
± 20
Ph1b-Refametinib/Regorafenib Cohort -1a
1642.7
± 98
Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-5Primary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
1148.8
± 90
Ph1b-Refametinib/Regorafenib Cohort -1a
1485.7
± 255
Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for RegorafenibPrimary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
32359.4
± 32
Ph1b-Refametinib/Regorafenib Cohort -1a
34352.2
± 38
Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-2Primary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
24139.7
± 34
Ph1b-Refametinib/Regorafenib Cohort -1a
25826.2
± 100
Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-5Primary· 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.
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
NA
± NA
Ph1b-Refametinib/Regorafenib Cohort -1
20531.8
± 106
Ph1b-Refametinib/Regorafenib Cohort -1a
24029.3
± 265
Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Refametinib and Its Metabolite M-11Secondary· Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose
Maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Refametinib
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
549.7
± 58
Ph1b-Refametinib/Regorafenib Cohort -1
273.3
± 82
Ph1b-Refametinib/Regorafenib Cohort -1a
253.0
± 38
Metabolite M-11
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
58.7
± 10
Ph1b-Refametinib/Regorafenib Cohort -1
37.0
± 83
Ph1b-Refametinib/Regorafenib Cohort -1a
35.7
± 42
Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Refametinib and Its Metabolite M-11Secondary· Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose
Time to reach maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Median and full range were reported.
Refametinib
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
2.5
1.00 – 4.02
Ph1b-Refametinib/Regorafenib Cohort -1
1.0
0.77 – 7.50
Ph1b-Refametinib/Regorafenib Cohort -1a
4.0
0.97 – 8.00
Metabolite M-11
Group
Value
95% CI
Ph1b-Refametinib/Regorafenib Cohort 0
6.0
4.02 – 8.00
Ph1b-Refametinib/Regorafenib Cohort -1
4.0
1.80 – 7.50
Ph1b-Refametinib/Regorafenib Cohort -1a
4.0
1.93 – 8.00
Adverse events — posted to ClinicalTrials.gov
Time frame: From the start of study treatment until 30 days after last dose of study drug treatment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ph1b - Refametinib/Regorafenib Cohort 0
Serious: 0/2 (0%)
Deaths: —
Ph1b - Refametinib/Regorafenib Cohort -1
Serious: 4/7 (57%)
Deaths: —
Ph1b - Refametinib/Regorafenib Cohort -1a
Serious: 5/11 (45%)
Deaths: —
Serious adverse events (12 terms)
Reaction
System
Ph1b - Refametinib/Regoraf…
Ph1b - Refametinib/Regoraf…
Ph1b - Refametinib/Regoraf…
Blood creatine phosphokinase increased
Investigations
—
—
—
Cholangitis
Hepatobiliary disorders
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Wound infection
Infections and infestations
—
—
—
Troponin increased
Investigations
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
—
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
Hypertension
Vascular disorders
—
—
—
Embolism
Vascular disorders
—
—
—
Other adverse events (124 terms — click to expand)
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 26 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02168777.