PHASE II STUDY OF BAY 43-9006 IN PATIENTS WITH ADVANCEDCHOLANGIOCELLULAR CARCINOMA - SORACCC
- Conditions
- ?Patients should have proven primary CCC according to one of the following criteria: oHistological evidence of CCC on a biopsy specimen.MedDRA version: 9.1Level: LLTClassification code 10004668Term: Biliary neoplasm
- Registration Number
- EUCTR2006-001014-32-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA POLICLINICO DI MODENA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?Age ?18 years.
?Patients should have proven primary CCC according to one of the following criteria:
oHistological evidence of CCC on a biopsy specimen.
oECOG 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:
oHemoglobin ? 8.5 g/dl
oAbsolute granulocytes ? 1.5 x 109/L
o Platelet count ? 60 x 109/L
oTotal serum bilirubin ? 3 mg/dl
oALT (SGOT) and AST (SGPT) ? 5 x upper limit of normal
oPT-INR? 2.3 or PT ? 6 seconds above control
oSerum 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
?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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1.Disease control (CR, PR, SD) at 12 weeks (RECIST)<br><br><br><br>2.Biomarker assessment: <br><br>?predictive value of baseline phospho-Raf-1 levels in tumors cells in immunohistochemistry<br><br>?predictive value of baseline phospho-MEK (pMEK) levels in tumors cells in immunohistochemistry<br><br>?predictive value of baseline phospho-ERK (pERK) levels in tumors cells in immunohistochemistry<br><br>?EGFR expression;Secondary Objective: ?Time to progression (TTP) <br><br>?Overall survival <br><br>?Toxicity;Primary end point(s): 1.Disease control (CR, PR, SD) at 12 weeks (RECIST)<br><br><br><br>2.Biomarker assessment: <br><br>?predictive value of baseline phospho-Raf-1 levels in tumors cells in immunohistochemistry<br><br>?predictive value of baseline phospho-MEK (pMEK) levels in tumors cells in immunohistochemistry<br><br>?predictive value of baseline phospho-ERK (pERK) levels in tumors cells in immunohistochemistry<br><br>?EGFR expression
- Secondary Outcome Measures
Name Time Method