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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004861-15 | EudraCT Number |
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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.
Number of treatment-emergent Adverse Events (AEs) will be reported in Adverse Events section.
Study was originally designed with both Phase I and Phase II part, but sponsor decided not to conduct Phase 2 part due to strategic portfolio re-prioritization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ph1b-Refametinib/Regorafenib Cohort 0 | Experimental | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off. |
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| Ph1b-Refametinib/Regorafenib Cohort -1 | Experimental | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off. |
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| Ph1b-Refametinib/Regorafenib Cohort -1a | Experimental | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refametinib (BAY86-9766) | Drug | Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level. In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib | Maximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 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 (Cmax,md) for Refametinib Metabolite M-11 | Maximum drug concentration in plasma after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 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 (AUC(0-12)md) for Refametinib | 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. | 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 (AUC(0-12)md) for Refametinib Metabolite M-11 | 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. | 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 (Cmax,md) for Regorafenib | Maximum drug concentration in plasma after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Refametinib and Its Metabolite M-11 | 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. | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose |
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Inclusion Criteria:
Criteria for the Phase 1b:
Cohort-specific criteria for Phase 2:
Baseline tumor tissue to conduct molecular and / or genetic studies should be available from all study patients enrolled in this study. (optional in Phase 1b)
Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. (applicable only in Phase 2)
Male or female patients ≥ 18 years of age (only female patients in breast cancer cohort of Phase 2).
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 3 months
Adequate bone marrow, liver and renal function
Cardiac function within normal range
Exclusion Criteria:
Prior treatment with refametinib or regorafenib.
Metastatic brain or meningeal tumors
Uncontrolled hypertension despite optimal medical management
History of cardiac disease
Arterial or venous thrombotic or embolic events
Any hemorrhage or bleeding event
History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
Any condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Excluded previous therapies and medications:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven | Connecticut | 06510 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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The remaining 20 participants were assigned to and started treatment in one of three dose escalation cohorts. The Phase 2 part was not conducted.
Study was planned to have two parts, Phase 1b part and Phase 2 part. For the Phase 1b part, altogether 34 participants were screened, and 14 out of them were screening failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ph1b-Refametinib/Regorafenib Cohort 0 | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Regorafenib (Stivarga, BAY73-4506) | Drug | Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level. In Phase 1b dose escalation, regorafenib will be administered in a 3-weeks-on / 1-week-off schedule except in one cohort, that uses regorafenib 2 weeks on / 2 weeks off regimen (dose level -2). In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used. |
|
| 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 (Cmax,md) for Regorafenib Metabolite M-2 | Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 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 (Cmax,md) for Regorafenib Metabolite M-5 | Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 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 (AUC(0-24)md) for Regorafenib | 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. | 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 (AUC(0-24)md) for Regorafenib Metabolite M-2 | 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. | 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 (AUC(0-24)md) for Regorafenib Metabolite M-5 | 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. | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
| Tumor Response During Phase 2 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes. | Up to 12 months |
| Number of Participants With Dose Limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) were analyzed in the maximum tolerated dose (MTD) analysis set, in which only the six first patients of each dose escalation Cohort could be included according to the modified Rolling-6 method that was applied in this study. | At Cycle 1 |
| Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Refametinib and Its Metabolite M-11 | 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. | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose |
| Area Under the Plasma Concentration-time Curve From 0 to 8 h (AUC(0-8)) After Single (First) Dose for Refametinib and Its Metabolite M-11 | Area under the plasma concentration-time curve from 0 to 8 h after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 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 Multiple Dose (Tmax,md) for Refametinib and Its Metabolite M-11 | Time to reach maximum drug concentration in plasma after multiple dose for Refametinib and its metabolite M-11. Median and full range were reported. | 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 Single (First) Dose (Cmax) for Regorafenib and Its Metabolites M-2 and M-5 | Maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose |
| Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Regorafenib and Its Metabolites M-2 and M-5 | Time to reach maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported. | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose |
| Area Under the Plasma Concentration-time Curve From 0 to 24 h (AUC(0-24)) After Single (First) Dose for Regorafenib and Its Metabolites M-2 and M-5 | Area under the plasma concentration-time curve from 0 to 24 h after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose |
| Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Regorafenib and Its Metabolites M-2 and M-5 | Time to reach maximum drug concentration in plasma after multiple dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported. | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
| Tumor Response During Phase 1b as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target and non-target tumor lesions, PR was defined as a decrease of at least 30% in the sum of diameters of target lesions, SD was defined neither sufficient shrinkage for PR nor sufficient increase for PD, PD was defined as an increase of at least 20% in the sum of diameters of target lesions. | From start of treatment until progression is documented |
| Overall Survival During Phase 2 | Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date. | Up to 12 months after last patient first visit |
| Time to Progression During Phase 2 | Time to progression was defined as the time (days) from the treatment start date to the disease progression on or following the start date. Participants not experiencing progression at the database cutoff date for primary completion were censored at the last assessment. | From start of treatment until progression is documented |
| Progression-free Survival During Phase 2 | Progression-free survival was defined as the time from date of treatment assignment to date of first observed disease progression or death due to any cause, if death occurred while the participant was in the study and before progression was observed. | From start of treatment until progression is documented |
| Detroit |
| Michigan |
| 48201 |
| United States |
| St Louis | Missouri | 63110 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Houston | Texas | 77030 | United States |
| Ph1b-Refametinib/Regorafenib Cohort -1 |
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off. |
| FG002 | Ph1b-Refametinib/Regorafenib Cohort -1a | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ph1b-Refametinib/Regorafenib Cohort 0 | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off. |
| BG001 | Ph1b-Refametinib/Regorafenib Cohort -1 | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off. |
| BG002 | Ph1b-Refametinib/Regorafenib Cohort -1a | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Cancer types | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib | Maximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | Pharmacokinetic (PK) analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose |
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| Primary | Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11 | Maximum drug concentration in plasma after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib | 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. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose |
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| 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 | 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. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose |
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| Primary | Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib | Maximum drug concentration in plasma after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| Primary | Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-2 | Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| Primary | Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-5 | Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib | 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. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| 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 | 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. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| 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 | 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. | PK analysis set for multiple dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| Primary | Tumor Response During Phase 2 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes. | Phase 2 part was not conducted. | Posted | Up to 12 months |
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| Secondary | Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Refametinib and Its Metabolite M-11 | 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. | PK analysis set for single dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose |
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| Secondary | Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Refametinib and Its Metabolite M-11 | 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. | PK analysis set for single dose. | Posted | Median | Full Range | h | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 to 8 h (AUC(0-8)) After Single (First) Dose for Refametinib and Its Metabolite M-11 | Area under the plasma concentration-time curve from 0 to 8 h after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for single dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose |
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| Secondary | Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Refametinib and Its Metabolite M-11 | Time to reach maximum drug concentration in plasma after multiple dose for Refametinib and its metabolite M-11. Median and full range were reported. | PK analysis set for multiple dose. On Day 21, one patient in Cohort 0 was dose reduced and the other patient was not dosed. Therefore no patient was evaluable. | Posted | Median | Full Range | h | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose |
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| Secondary | Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Regorafenib and Its Metabolites M-2 and M-5 | Maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for single dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/L | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose |
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| Secondary | Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Regorafenib and Its Metabolites M-2 and M-5 | Time to reach maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported. | PK analysis set for single dose. | Posted | Median | Full Range | h | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 to 24 h (AUC(0-24)) After Single (First) Dose for Regorafenib and Its Metabolites M-2 and M-5 | Area under the plasma concentration-time curve from 0 to 24 h after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | PK analysis set for single dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*h/L | Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose |
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| Secondary | Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Regorafenib and Its Metabolites M-2 and M-5 | Time to reach maximum drug concentration in plasma after multiple dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported. | PK analysis set for multiple dose. On Day 21, one patient in Cohort 0 was dose reduced and the other patient was not dosed. Therefore no patient was evaluable. | Posted | Median | Full Range | h | Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose |
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| Secondary | Tumor Response During Phase 1b as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target and non-target tumor lesions, PR was defined as a decrease of at least 30% in the sum of diameters of target lesions, SD was defined neither sufficient shrinkage for PR nor sufficient increase for PD, PD was defined as an increase of at least 20% in the sum of diameters of target lesions. | Full analysis set | Posted | Number | Participants | From start of treatment until progression is documented |
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| Secondary | Overall Survival During Phase 2 | Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date. | Phase 2 part was not conducted. | Posted | Up to 12 months after last patient first visit |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression During Phase 2 | Time to progression was defined as the time (days) from the treatment start date to the disease progression on or following the start date. Participants not experiencing progression at the database cutoff date for primary completion were censored at the last assessment. | Phase 2 part was not conducted. | Posted | From start of treatment until progression is documented |
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| Secondary | Progression-free Survival During Phase 2 | Progression-free survival was defined as the time from date of treatment assignment to date of first observed disease progression or death due to any cause, if death occurred while the participant was in the study and before progression was observed. | Phase 2 part was not conducted. | Posted | From start of treatment until progression is documented |
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| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Dose-limiting toxicities (DLTs) were analyzed in the maximum tolerated dose (MTD) analysis set, in which only the six first patients of each dose escalation Cohort could be included according to the modified Rolling-6 method that was applied in this study. | MTD analysis set: all participants who completed Cycle 1 or discontinued during Cycle 1 due to an adverse event or DLT in the dose escalation part. | Posted | Number | Participants | At Cycle 1 |
|
From the start of study treatment until 30 days after last dose of study drug treatment.
One subject had an Adverse Event which resulted in death, which was judged as unrelated to both study drugs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ph1b - Refametinib/Regorafenib Cohort 0 | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off. | 0 | 2 | 2 | 2 | ||
| EG001 | Ph1b - Refametinib/Regorafenib Cohort -1 | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off. | 4 | 7 | 7 | 7 | ||
| EG002 | Ph1b - Refametinib/Regorafenib Cohort -1a | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off. | 5 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lip disorder | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Groin infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mastitis fungal | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Electrocardiogram PR prolongation | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Genital burning sensation | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
|
The sponsor decided not to conduct the Phase 2 part of the study due to strategic portfolio re-prioritization.
Written consent must be obtained from Bayer prior to any information being submitted for publication. Material proposed for publication or presentation must be provided to Bayer at least 60 days prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C544830 | N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide |
| C559147 | regorafenib |
Not provided
Not provided
Not provided
| Male |
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| Other |
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| Non-small cell lung cancer |
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| Breast cancer |
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| Pancreatic adenocarcinoma |
|
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Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
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|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
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Phase 2 part of study: Participants will receive the recommended Phase 2 dose (RP2D) for Refametinib and Regorafenib combination therapy determined in Phase 1b part. Target population for this group will be Her-2 negative breast cancer (BC). |
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|
|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
|
|
|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off. |
|
|
| OG002 | Ph1b-Refametinib/Regorafenib Cohort -1a | Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off. |
|
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|
Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
|
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