Clinical trial · Interventional
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.
A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
NCT01204177CI-TRIAL-00012024BASILcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY86-9766 MEK Inhibitor + Sorafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: BAY86-9766 MEK Inhibitor + Sorafenib
Primary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- From first dose of combination treatment until last tumor evaluation
Secondary outcomes (8)
- measure
- Overall Survival (OS)
- timeFrame
- 1st dose of study medication to last date of follow up
- measure
- Time To Progression (TTP)
- timeFrame
- 1st dose of study medication until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female age \>/= 18 years of age * Life expectancy \>/= 12 weeks * Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic * Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1 * Adequate bone marrow, liver and renal function 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: * Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy * Radiotherapy within 4 weeks prior to start of study treatment * Any other investigational agents within 4 weeks from the first dose of study treatment * Major surgery within 4 weeks of start of study * Concomitant use of strong inhibitors and strong inducers of CYP3A4
References
Publications (1)
- DERIVEDLim 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. PMID 25294897