EUCTR2011-004063-77-DE进行中（未招募）1 期
Gemcitabine in Combination with the Oral Irreversible ErbB Inhibitor Afatinib versus Gemcitabine Alone in Patients with Metastatic Pancreatic Cancer: an Explorative Randomized Phase II Trial - Afatinib as Cancer therapy for Exocrine Pancreatic Tumours
Klinikum der Universität München, Anstalt des öffentlichen Rechts0 个研究点目标入组 119 人开始时间: 2012年8月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 119
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
- •1. Written informed consent in advance of any study-specific procedure
- •2. Histologically (not cytologically) confirmed diagnosis of metastatic pancreatic adenocarcinoma (stage IV according to UICC 2009 classification: each T, each N, M1)
- •3. Availability of tumour samples
- •4. Informed consent that tumour- and blood samples are centrally collected and will serve for translational analyses according to the study protocol
- •5. Age = 18 years
- •6. ECOG 0-1
- •7. Life expectancy at least 3 months
- •8. No option for surgical resection or radiation in curative intent
- •9. At least one measurable tumour lesion (CT-scan or MRI) according to RECIST Version 1.1
- •10. Possibility of long-term follow-up
- •11. Negative pregnancy test in fertile females
- •12. Given legal capacity of the patient
- •13. Adequate hepatic, renal and bone marrow function, defined as:
- •- absolute neutrophil count > 1500/µl
- •- hemoglobin > 9 g/dl
- •- thrombocytes > 100 000/µl
- •- serum bilirubin < 2 x ULN (liver metastasis < 5 x ULN)
- •- serum creatinin < 1.5 x ULN
- •- creatinin clearance > 30 ml/min (Cockroft/Gault)
- •- transaminases < 2.5 x ULN (liver metastasis < 5 x ULN)
- •- albumin > 25 g/L
- •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
- •1. Evidence of weight loss > 15 % within one month
- •2. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids) or leptomeningeal disease. Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded
- •3. Previous gemcitabine treatment is allowed only if applied as monotherapy in the adjuvant setting (after potential curative R0 or R1 resection), and if the adjuvant single-agent gemcitabine chemotherapy was terminated at least 6 months before study entry
- •4. Previous systemic treatment with chemotherapy or radiotherapy for locally advanced, non resectable or metastatic pancreatic cancer
- •5. Radiotherapy within four weeks prior to randomization or radiation of target lesions
- •6. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past 4 weeks before start of therapy or concomitantly with this trial
- •7. Hypersensitivity to afatinib or to gemcitabine or to any of the excipients or to compounds with similar chemical or biologic composition
- •8. Contraindications against the use of gemcitabine
- •9. Severe renal insufficiency (baseline creatinine clearance < 30 ml/mi)
- •10. LDH elevated by >2.5 ULN
- •11. Severe hepatic dysfunction (bilirubin = 2.0 x ULN, transaminases = 2.5 x ULN or = 5 x ULN in case of liver metastases)
- •12. Any disease e. g. 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, metabolic dysfunction giving reasonable suspicion of a disease or condition that contra-indicates the use of the study drugs or puts the patient at high risk for treatment-related complications
- •13. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn’s disease, malabsorption or CTC grade =2 diarrhoea of any aetiology
- •14. Pregnant or lactating females, non-effective contraception in men and women of childbearing potential (an effective contraceptive measure has a Pearl Index <1)
- •15. Any major surgery within the last 2 weeks before study entry
- •16. Chemo- or immunotherapy within the past 4 weeks
- •17. Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
- •18. Any persisting toxicities which are deemed to be clinically significant from the previous therapy
- •19. Patients with pre-existing interstitital lung disease
- •20. Psychological, familial, social or geographic conditions that may prevent an adequate compliance with the study protocol
- •21. Known or suspected alcohol- or drug abuse
- •22. Patients unable to comply with the protocol
- •23. Known hepatitis B infection, known hepatitis C infection or HIV carrier
- •24. Requirement for treatment with any of the prohibited concomitant medications listed in section 4.3.2
- •25. 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
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