Advanced Pancreatic carcinoma MedDRA version: 9.1 Level: HLT Classification code 10033633 Term: Pancreatic neoplasms malignant (excl islet cell and carcinoid)
Conditions
Interventions
Trade Name: Tarceva
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Erlotinib
CAS Number: 183321-74-6
Current Sponsor code: Ro 50-8231
Concentration unit: mg milligram(s)
Concentration t
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease specific inclusion criteria: 1. Histologically or cytologically confirmed locally advanced-unresectable or metastatic pancreatic cancer where tumor is accessible for biopsy 2. Measurable disease according to RECIST (irradiated lesions can not be used as target lesions) 3. Failure of at least one prior chemotherapy regimen or patients who are deemed unsuitable for chemotherapy in the investigators opinion. There must be > 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC 6 weeks General inclusion criteria: 6. Age > 18 years 7. ECOG performance status of 0 - 2 8. Able to comply with the protocol 9. Written (signed) Informed Consent to participate in the study 10. Patient must be willing and able to undergo biopsy according to the institute?s own guidelines and requirements for such procedures. 11. Adequate hematological function: ANC > 1.5 x 109/L, platelet count > 100 x 109/L and Hb > 9 g/dL 12. INR 2.5 g/dL 16. Adequate renal function: serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease specific exclusion criteria: 1. Local (Stage IA to IIB) pancreatic cancer and locally advanced-resectable pancreatic cancer. 2. Prior treatment with an investigational or marketed agent which acts on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors 3. Any other malignancies within the last 5 years before randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer 4. Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 4 weeks before randomization) in case of clinical suspicion or evidence of brain metastases General exclusion criteria 5. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA ( grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease, metabolic dysfunction), physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications Etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Sopravvivenza libera da progressione;Secondary Objective: Overall survival Response rate Disease control rate Safety;Main Objective: Identification of biomarker(s) which may predict improvement in PFS from treatment with erlotinib. | — |
Countries
Bulgaria, Germany, Italy, Latvia, Lithuania, Slovenia, United Kingdom
Outcome results
None listed