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This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refametinib (BAY86-9766)+ Gemcitabine | Experimental | Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Refametinib (BAY86-9766) | Drug |
| ||
| Gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of BAY86-9766 | Multiple time points up to 6 day | |
| Plasma concentration of M17 and M11 | Multiple time points up to 6 day | |
| Plasma concentration of Gemcitabine | Multiple time points up to 6 day | |
| Plasma concentration of dFdU | Multiple time points up to 6 day | |
| Number of adverse events, or abnormal parameters as a measure of safety and tolerability | Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BAY86-9766 shown by a discrete scale | Elements of the scale are :Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai | 200032 | China | ||||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C544830 | N-(3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-6-methoxyphenyl)-1-(2,3-dihydroxypropyl)cyclopropane-1-sulfonamide |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
|
| Kashiwa |
| Chiba |
| 277-8577 |
| Japan |
| Seoul | 03080 | South Korea |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |