EUCTR2020-005182-14-FR进行中（未招募）1 期
An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma - OPTIMIZE-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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.Has provided written informed consent
- •2.Is =18 years of age at the time of signing the informed consent form (ICF)
- •3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4. Has a diagnosis of previously untreated metastatic pancreatic ductal adenocarcinoma (histologically documented)
- •5. Has measurable disease per RECIST v. 1.1
- •6. Has not received previous chemotherapy for pancreatic ductal adenocarcinoma
- •7. Has not received prior abdominal radiotherapy (except for palliative radiotherapy to non-target l lesions)
- •8. Has a life expectancy of = 3 months
- •9. Has acceptable hematologic laboratory values
- •defined as:
- •a. Neutrophils = 1.5 x 10^9/L without growth factor
- •stimulation within 3 weeks prior to the blood test
- •b. Platelets =100 x 10^9/L
- •c. Hemoglobin =5.9 mmol/L (~95 g/L) (may be after transfusion)
- •10. Has acceptable clinical chemistry laboratory values
- •defined as:
- •a. Bilirubin =1.5 x ULN (biliary drainage is permitted)
- •b. AST =3 x ULN (irrespective of hepatic metastases)
- •c. ALT =3 x ULN (irrespective of hepatic metastases)
- •d. Creatinine =1.5 x ULN or glomerular filtration rate
- •(GFR) of =45 mL/min (see APPENDIX 4 for calculation of GFR)
- •e. INR =1.5 x ULN
- •f. Albumin =28 g/L
- •11. For women of childbearing potential:
- •a. Has a negative highly sensitive serum (ß-human chorionic gonadotropin [ß-hCG]) pregnancy test at
- •b. Is willing to use highly effective contraception
- •methods (defined in APPENDIX 5) during study treatment and for at least six months thereafter
- •12. Is willing to comply with all study procedures
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Has other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar
- •cell adenocarcinoma, cyst adenocarcinoma and ampullary carcinoma
- •2. Has other current cancer or history of cancer in
- •the prior 3 years before signing the ICF other than in situ cervical cancer, or basal cell or squamous cell carcinoma treated with local excision only
- •3. Has known CNS metastases or carcinomatous meningitis
- •4. Has contraindication to any constituent of study treatment (mitazalimab and applicable chemotherapy)
- •5. Has a history of chronic diarrhea, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
- •6. Has a history of myocardial infarction within 12 months of the first administration of mitazalimab, uncontrolled angina pectoris, unstable cardiac arrhythmias, or congestive heart failure of New York Heart Association class II or greater
- •7. Has QTc >450 msec if male and QTc >470 msec if female
- •8. Has uncontrolled intercurrent illness, including active infection
- •9. Has a known history of HIV, hepatitis B or active hepatitis C infection
- •10. Is a female patient who is pregnant or nursing
- •11. Has received attenuated vaccine within 28 days
- •before the first dose of study treatment
- •12. Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient’s compliance with the study
- •Additional exclusion criteria only applicable for mFOLFIRINOX treatment:
- •13. Has received prior treatment with irinotecan or platinum-containing chemotherapy
- •14. Has pre-existing peripheral neuropathy greater
- •than grade 1
- •15. Has known Gilbert's disease
- •16. Has known genotype UGT1A1 * 28 / * 28
- •17. Has known fructose intolerance (malabsorption)
- •18. Has complete dihydropyrimidine dehydrogenase (DPD) deficiency
- •Additional exclusion criteria only applicable for gemcitabine plus nab-paclitaxel treatment:
- •13. Has a history of slowly progressive dyspnea and unproductive cough, or of conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity, pneumonitis or multiple allergies
- •14. Has a history of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease)
- •15. Has a history of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
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