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This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY86-9766 MEK Inhibitor + Sorafenib | Drug | All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | From first dose of combination treatment until last tumor evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 1st dose of study medication to last date of follow up | |
| Time To Progression (TTP) | 1st dose of study medication until disease progression | |
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Inclusion Criteria:
Exclusion Criteria:
Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
Renal failure requiring hemo- or peritoneal dialysis
Known human immunodeficiency virus (HIV) infection
Known history or symptomatic metastatic brain or meningeal tumors
History of organ allograft.
History of interstitial lung disease (ILD).
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 |
|---|---|---|---|---|---|---|
| Shatin | New Territories | Hong Kong | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25294897 | Derived | Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, Rau KM, Poon RT, Yeo W, Park JW, Tay MH, Hsieh WS, Kappeler C, Rajagopalan P, Krissel H, Jeffers M, Yen CJ, Tak WY. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):5976-85. doi: 10.1158/1078-0432.CCR-13-3445. Epub 2014 Oct 7. |
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|
| Response Rate (RR) |
| 1st dose of study medication until last tumor evaluation |
| Duration Of Response (DOR) | 1st dose of study medication until last tumor evaluation |
| Safety: physical examination, vital signs, adverse events, safety lab | At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT |
| Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL) | At day 1 of each cycle and within 7 day after the last treatment |
| Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients) | Day -3, cycle 2 (day 1) |
| Biomarkers | At screening, day 1 of cycle 1 - 4, EOT |
| Hong Kong |
| Hong Kong |
| Singapore | 228510 | Singapore |
| Singapore | 258499 | Singapore |
| Junggu | Daegu Gwang''yeogsi | 700-721 | South Korea |
| Goyang-si | Gyeonggido | 410-769 | South Korea |
| Busan | 602-739 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 138-736 | South Korea |
| Kaohsiung City | 833 | Taiwan |
| Tainan | 736 | Taiwan |
| Tainan | Taiwan |
| Taipei | 100 | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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