E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033605 |
E.1.2 | Term | Pancreatic cancer metastatic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033606 |
E.1.2 | Term | Pancreatic cancer non-resectable |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Identification of biomarker(s) which may predict improvement in progression free survival from treatment with erlotinib |
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E.2.2 | Secondary objectives of the trial |
Assessment of efficacy and safety |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically or cytologically confirmed locally advanced-unresectable or metastatic pancreatic cancer 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. >= 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC <= 1) from acute toxicities of any previous therapy (with the exception of alopecia). 4. Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC <= 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to randomization. 5. Life expectancy of ≥ 6 week 6. Age >= 18 years 7. ECOG performance status of 0 - 1 (see section 5.3.2) 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 <= 1.5 and PTT <=1.5 x ULN within 7 days prior to randomization 13. Platelet aggregation inhibitors must discontinued within an appropriate time period before biopsy 14. Adequate liver function: Serum (total) bilirubin <= 1.5 x ULN, SGOT (AST) and SGPT (ALT) < 2.5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases, 15. Albumin >= 2.5 g/dL 16. Adequate renal function: serum creatinine < 1.5 ULN 17. Normal serum calcium 18. For all females of childbearing potential a negative pregnancy test must be obtained within 7 days before start of treatment.
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E.4 | Principal 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 study start, 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 study start) in case of clinical suspicion or evidence of brain metastases 5. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (<= 6 months before study start), myocardial infarction (<= 6 months before study start), unstable angina, NYHA >= 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 6. Patients who have had any major surgery within 2 weeks prior to study start 7. Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended) 8. Patients unable to take oral medication, requiring intravenous alimentation, who have mal-absorption syndrome or any other conditions affecting gastrointestinal absorption, or who have active peptic ulcer disease 9. Pregnant or lactating females 10. Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) 11. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study 12. Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection. 13. Patients using coumadin or warfarin 14. Known hypersensitivity to any of the study drugs or their excipients.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Assessment of EGFR expression and gene copy number in tumor tissue - Assessment of HER2 and HER3 expression in tumor tissue - Assessment k-RAS mutation status in tumor tissue - Assessment of EGFR ligands in serum and tissue - EGFR Intron 1 polymorphism in blood
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end when the last patient has stopped treatment with erlotinib or placebo. The cut off date for the statistical analysis will be 6 months after last patient randomized. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |