EUCTR2010-019214-25-SE进行中（未招募）1 期
Safety, pharmacokinetics and efficacy of AXP107-11 in combination with standard gemcitabine (Gemzar®) treatment in patients with locally advanced or metastatic, unresectable, adenocarcinoma of the pancreas, stage III-IV. A prospective, open label, multi-centre, sequential phase Ib/IIa study.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •Inclusion criteria
- •1. Age = 18 years at the time of signing the informed consent
- •2. Histologically confirmed adenocarcinoma of the pancreas
- •3. Metastatic or locally advanced, unresectable disease stage III-IV.
- •4. Measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid tumors (RECIST) for target lesions
- •5. Karnofsky Performance Status = 70 at study entry (Appendix 18.4).
- •6. Life expectancy of more than three months
- •7. Negative pregnancy test for female patients
- •8. For fertile women, willingness to perform double-barrier contraception during study and for four weeks after last treatment
- •9. Able and willing to sign the informed consent form
- •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
- •Exclusion criteria
- •1. Previous or ongoing severe supraventricular or ventricular arrhythmia
- •2. Previous or ongoing coagulation or bleeding disorder (PTT > 1.5 x ULN)
- •3. HIV infection
- •4. Known hypersensitivity to any component of the AXP107-11 formulation or gemcitabine
- •5. Previous or ongoing significant liver pathology (other than metastases) and/or liver function disorders
- •6. Previous or ongoing significant chronic renal dysfunction
- •7. Previous or ongoing malignancy other than pancreatic cancer < five years prior to enrolment, except basal cell carcinoma treated locally
- •8. Cardiovascular disease, New York Heart Association (NYHA) classification III or IV
- •9. Severe pulmonary obstructive or restrictive disease
- •10. Acute or chronic inflammation (autoimmune or infectious)
- •11. Significant active/unstable non-malignant disease likely to interfere with study assessments
- •12. Laboratory tests (hematology, chemistry) outside specified limits:
- •-WBC = 3 x 10³/mm³
- •-ANC = 1.5 x 10³/mm³
- •-Platelets = 100.000/mm³
- •-Hb = 9.0 g/dl (= 5.6 mmol/l)
- •-PT/PTT > 3 x ULN
- •-Serum creatinine > 130 µmol/l) or clearance < 60 ml/min
- •-AST and/or ALT > 3 x ULN with the exception of patients with liver metastasis (> 5 x ULN)
- •-Alkaline phosphatase > 3 x ULN
- •-Total bilirubin > 3 x ULN
- •13. Immunotherapy within six weeks prior to enrolment.
- •14. Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrolment
- •15. Any radiotherapy for pancreatic adenocarcinoma before enrolment except for treatment of bone metastases if target lesions are not included in the irradiated field
- •16. Major surgery within four weeks prior to enrolment
- •17. Pregnant or nursing woman
- •18. Participations in other interventional clinical study within four weeks of enrolment
研究者
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