Subjects enrolled in this study must have histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma. They must not have been received a first-line chemotherapy. Presence of at least one target lesion measurable by CT scan or MRI in not an irradiated area (and conform with the RECIST criteria MedDRA version: 6.1 Level: PT Classification code 10033609
Conditions
Interventions
Trade Name: NEXAVAR*112CPR RIV 200MG
Pharmaceutical Form: Tablet
INN or Proposed INN: nexavar
CAS Number: 284461-73-0
Current Sponsor code: BAY 43-9006
Concentration unit: mg milligram(s)
Concentratio
Sponsors
GISCAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Signed written informed consent prior to beginning protocol specific procedures  Male or female =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  Brain metastases  Previous chemotherapy for locally advanced or metastatic pancreatic cancer.  Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)  Radiotherapy within 4 weeks prior to study entry  Major surgery within 4 weeks of first dose of study drug  Concurrent chronic systemic immune therapy  Any investigational agent(s) 4 weeks prior to entry  Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months  Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months  Acute or subacute intestinal occlusion or history of inflammatory bowel disease  Known grade 3 or 4 allergic reaction to any of the components of the treatment  Known drug abuse/ alcohol abuse  Legal incapacity or limited legal capacity  Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent  Women who are pregnant or breastfeeding  Acute or subacute intestinal occlusion  Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - overall Response Rate (RECIST Criteria) - duration of response - time to treatment failure - overall survival time;Primary end point(s): The primary activity parameter to be determined is Progression Free Survival.;Main Objective: The primary activity parameter to be determined is Progression Free Survival. | — |
Countries
Italy
Outcome results
None listed