? Patients should have proven primary CCC according to one of the following criteria: o Histological evidence of CCC on a biopsy specimen. MedDRA version: 9.1 Level: LLT Classification code 10004668 Term: Biliary neoplasm
Conditions
Interventions
Product Name: Sorafenib
Pharmaceutical Form: Tablet
INN or Proposed INN: Sorafenib
Current Sponsor code: Bay 43-9006
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age ?18 years. ? Patients should have proven primary CCC according to one of the following criteria: o Histological evidence of CCC on a biopsy specimen. o ECOG Performance Status of 0 or 1 (see appendix 8.4). ? Patients with at least one measurable lesion by CT-scan or MRI according to the RECIST criteria, performed within 4 weeks prior to start of dosing. ? Patients who have received systemic 1st or 2nd line chemotherapy ? Patients who have received local therapy, such as: surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ?25% in the size. Furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion (Lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfill the conditions described above). ? Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: o Hemoglobin ? 8.5 g/dl o Absolute granulocytes ? 1.5 x 109/L o Platelet count ? 60 x 109/L o Total serum bilirubin ? 3 mg/dl o ALT (SGOT) and AST (SGPT) ? 5 x upper limit of normal o PT-INR? 2.3 or PT ? 6 seconds above control o Serum creatinine ? 1.5 x upper limit of normal. ? Written Informed Consent must be obtained and documented prior to any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Congestive heart failure defined as NYHA class III or IV. ? Serious cardiac arrhythmias. ? Active coronary artery disease or ischemia. ? Active clinically serious infections (> grade 2 NCI-CTC). ? Known history of HIV infection. ? Known metastatic brain or meningeal tumors. ? History of seizure disorder. ? History of organ allograft. ? Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis & T1] or other malignancies curatively treated > 3 years prior to entry). ? Patients with clinically significant gastrointestinal bleeding within the past month prior to study entry are ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Disease control (CR, PR, SD) at 12 weeks (RECIST) 2. Biomarker assessment: ? predictive value of baseline phospho-Raf-1 levels in tumors cells in immunohistochemistry ? predictive value of baseline phospho-MEK (pMEK) levels in tumors cells in immunohistochemistry ? predictive value of baseline phospho-ERK (pERK) levels in tumors cells in immunohistochemistry ? EGFR expression;Secondary Objective: ? Time to progression (TTP) ? Overall survival ? Toxicity;Primary end point(s): 1. Disease control (CR, PR, SD) at 12 weeks (RECIST) 2. Biomarker assessment: ? predictive value of baseline phospho-Raf-1 levels in tumors cells in immunohistochemistry ? predictive value of baseline phospho-MEK (pMEK) levels in tumors cells in immunohistochemistry ? predictive value of baseline phospho-ERK (pERK) levels in tumors cells in immunohistochemistry ? EGFR expression | — |
Countries
Italy
Outcome results
None listed