EUCTR2015-000905-38-IT进行中（未招募）1 期
A randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton’s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma - Not available
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
- 424
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. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
- •2. Stage IV disease diagnosed within 6 weeks of randomization.
- •3. Disease which is evaluable according to RECIST 1.1, with at least one measurable metastatic lesion (not in a previously irradiated area).
- •4. Disease status for which, in the opinion of the investigator, nabpaclitaxel and gemcitabine is considered an appropriate treatment choice.
- •5. No previous radiotherapy, surgery, cytotoxic chemotherapy or investigational therapy for the treatment of metastatic pancreatic adenocarcinoma.
- •6. No prior neo-adjuvant, peri-operative or adjuvant chemotherapy for primary disease of pancreaatic adenocarcinoma. Prior treatment with 5- FU, gemcitabine or capecitabine administered as a radiation sensitizer (at non-cytotoxic doses) in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose.
- •7. No clinically significant third-space fluid accumulation (eg, ascites or pleural effusion).
- •8. Male and female subjects of reproductive potential who agree to use highly effective methods of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (eg, condoms, cervical ring, sponge, etc) during the period of therapy and for 6 months for males and females after the last dose of study medication.
- •9. Ability to provide written informed consent and to understand and comply with the requirements of the study.
- •10. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to randomization:
- •Absolute neutrophil count (ANC) =1.5 x 109/L
- •Platelet count =100 x 109/L
- •Hemoglobin =9 g/dL
- •11. Adequate hepatic and renal function defined as:
- •Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =5.0 x upper limit of normal (ULN) if liver metastases, or =3 x ULN
- •without liver metastases
- •Alkaline phosphatase <3.0 x ULN or =5.0 x ULN if liver or bone metastases present
- •Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis)
- •Estimated Creatinine Clearance =30 mL/min (Cockcroft-Gault)
- •12. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN.
- •Demographic
- •13. Men and women =18 years of age.
- •14. Karnofsky performance status (KPS) =70. Two observers will be required to assess KPS at screening. If discrepant, the one with the
- •lowest assessment will be accepted.
- •15.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •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 226
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •To be enrolled in the study, potential subjects must meet NONE of the following exclusion criteria:
- •Disease-related
- •1. Prior radiotherapy to any measurable lesion at any time.
- •2. Radiotherapy in the adjuvant setting, or earlier, within the last six months.
- •3. Previous cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
- •4. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- •Concurrent Conditions
- •5. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system
- •involvement).
- •6. Prior exposure to BTK inhibitor.
- •7. A documented =10% decrease in KPS between screening visit and within 72 hours prior to randomization.
- •8. History of other malignancies, except:
- •Malignancy treated with curative intent and with no known active disease present for =3 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •Adequately treated carcinoma in situ without current evidence of disease.
- •9. Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
- •10. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
- •11. Live vaccination within 4 weeks prior to randomization.
- •12. Any uncontrolled active systemic infection including any infection requiring systemic IV treatment which was completed =7 days before
- •randomization.
- •13. Major surgery within 4 weeks of first dose of study drug.
- •14. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
- •15. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- •16. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as
- •defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary
- •syndrome within 6 months prior to randomization.
- •17. History of interstitial lung disease, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
- •18. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the
- •stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
- •19. Concomitant use of warfarin or other Vitamin K antagonists.
- •20. Known hypersensitivity to any study drug (nab-paclitaxel, gemcitabine, or ibrutinib)
- •21. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
- •22. Currently active, clinically significant hepatic impairment (Class B or C) acording to the Child- Pugh classification
- •23. Lactating or pregnant.
- •24. Unwilling or unable to participate in all required study evaluations and procedures.
- •25. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance w
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