EUCTR2012-004429-26-DE进行中（未招募）1 期
A Phase Ib/IIa study of combination therapy with Gemcitabine and Atu027 in subjects with locally advanced or metastatic pancreatic adenocarcinoma - Atu027-I-02
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Lead-in safety period:
- •1. Subjects between the age of 18 and 84 years
- •2. Histologically or cytologically confirmed advanced or refractory cholangiocellular carcinoma, biliary tract cancer, non-small-cell lung carcinoma, duodenal cancer, soft tissue sarcoma, ovarian carcinoma, or another non-pancreatic cancer disease indicated for gemcitabine treatment as determined by the investigator
- •3. Subjects who have previously received chemotherapy and standard curative or palliative care is not available, not effective, or unlikely to be effective
- •4.No option for surgical resection or radiation in curative intent
- •5.Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 – 2
- •6.Life expectancy of at least 3 months
- •7.No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- •8.Alanine aminotransferase (ALT) =3.0 x upper limit of normal (ULN; =5 x ULN for subjects with liver metastases)
- •9.Aspartate aminotransferase (AST) =3.0 x ULN (=5 x ULN for subjects with liver involvement with cancer)
- •10.Total bilirubin =2.0 x ULN (liver metastasis <5 x ULN)
- •11.Serum creatinine =1.5 x ULN
- •12.Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 106/L) and platelet count of 100,000 (x 106/L) prior to the initiation of a cycle.
- •13.Prothrombin time-international normalized ratio/partial thromboplastin time (PT-INR/PTT) <1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (=100 mg daily).
- •14. Women of childbearing potential must have a negative urine pregnancy test at baseline.
- •15. Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
- •16. Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
- •17. Subjects must be willing and able to give written informed consent.
- •1.Subjects between the age of 18 and 84 years
- •2.Locally advanced or metastatic pancreatic adenocarcinoma stage III/IV
- •3.No option for surgical resection or radiation in curative intent
- •4.Histological or cytological documentation of non-hematologic, malignant solid tumor
- •5.At least one measurable lesion or evaluable disease, as per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
- •6.Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
- •7.Life expectancy of at least 3 months
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Lead-in safety period:
- •1. History of cardiac disease; congestive heart failure >New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
- •2. Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) =7%
- •3. Poorly controlled hypertension, defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management
- •4. Poorly controlled seizure disorder
- •5. Subjects undergoing renal dialysis
- •6. Known hypersensitivity to the study drugs or active substances or excipients of the preparations
- •7. Pregnant or breast feeding
- •8. Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject’s record)
- •9. Previous participation in this study
- •10. Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study.
- •11. Subject is a relative of, or staff directly reporting to the investigator.
- •12. Subject is an employee of the sponsor.
- •13. Subject is committed under official or judicial order.
- •14. Any other reason that the investigator considers makes the subject unsuitable to participate
- •1. History of cardiac disease; congestive heart failure >New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
- •2. Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) =8%
- •3. Poorly controlled hypertension, defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management
- •4. Poorly controlled seizure disorder
- •5. Subjects undergoing renal dialysis
- •6. Anticancer chemotherapy or immunotherapy during the study or before first study treatment. Subjects with recurrent disease after adjuvant treatment not progression-free for at least 6 months.
- •7. Radiotherapy to target lesions during study or before study start
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