EUCTR2007-003738-40-IT进行中（未招募）不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva)in Patients with Advanced Pancreatic Carcinoma. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 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 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 < 1.5 and PTT < 1.5 x ULN within 7 days prior to randomization
- •13. Platelet aggregation inhibitors must be 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 for SGOT (AST) and SGPT (ALT) in case of liver metastases,
- •15. Albumin > 2.5 g/dL
- •16. Adequate renal function: serum creatinine < 1.5 ULN
- •17. For all females of childbearing potential a negative pregnancy test must be obtained within 7 days before start of treatment.
- •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
排除标准
- •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 (< 6
- •months before randomization), myocardial infarction (< 6 months before randomization), 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
研究者
相似试验
进行中（未招募）
不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma - MARKPancreatic cancerEUCTR2007-003738-40-SIF. Hoffmann-La Roche200
进行中（未招募）
不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma - MARKMedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectablePancreatic cancerEUCTR2007-003738-40-LTF. Hoffmann-La Roche200
进行中（未招募）
不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma - MARKPancreatic cancerEUCTR2007-003738-40-GBF. Hoffmann-La Roche200
进行中（未招募）
不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients with Advanced Pancreatic Carcinoma - MARKMedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectablePancreatic cancerEUCTR2007-003738-40-BGF. Hoffmann-La Roche200
已完成
不适用
A phase II Biomarker Identification Trial for Erlotinib (Tarceva) in Patients with Advanced Pancreatic Carcinoma. - ND-C25 Malignant neoplasm of pancreasMalignant neoplasm of pancreasC25PER-110-08F. HOFFMANN-LA ROCHE LTD.,