EUCTR2015-000905-38-ES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
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
- 326
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
入选标准
- •To be enrolled in the study, each potential subject must satisfy all of the following inclusion criteria.
- •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, nab-paclitaxel 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 who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days 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 Gilberts 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 over 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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 196
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. Any uncontrolled active systemic infection including any infection requiring systemic IV treatment which was completed 7 days before randomization.
- •12. Major surgery within 4 weeks of first dose of study drug.
- •13. 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.
- •14. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- •15. 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.
- •16. History of interstitial lung disease, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
- •17. 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.
- •18. Concomitant use of warfarin or other Vitamin K antagonists.
- •19. Known hypersensitivity to any study drug (nab-paclitaxel, gemcitabine, or ibrutinib)
- •20. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
- •21. Lactating or pregnant.
- •22. Unwilling or
研究者
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