EUCTR2021-005790-60-AT招募中1 期
A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •A subject must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- •1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- •2. Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and nab-paclitaxel. Subjects who have had planned or prior surgery, such as a Whipple procedure, with or without neo-adjuvant/adjuvant chemotherapy may be included.
- •3. Life expectancy =3 months.
- •4. Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.
- •5. ECOG Performance Status 0-1.
- •6. Adult, age = 18 years, male or female.
- •7. Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception contraception from 2 weeks before the first administration of SBP-until 6 months after the last administration of the study drug (i.e., last dose of any of the three drugs in the regimen). Female subjects are considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, all with surgery at least one month before dosing). Male subjects with partners who are oCBP should also use a highly effective contraceptive measure during the study and
- •through 6 months following the last administration of study drug. Male subjects are considered of reproductive potential following puberty, unless permanently sterilized by bilateral vasectomy. Male subjects oCBP should be counseled to consider cryogenic preservation of sperm prior to study initiation due to the possibility of infertility post-treatment.
- •8. Adequate bone marrow, hepatic, renal, and coagulation function as defined by the following:
- •a. Absolute neutrophil count =1.5 x 109/L
- •b. Hemoglobin =9.0 g/dL (90 g/L)
- •c. Platelets =100 x 109/L
- •d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT =5 x ULN.
- •e. Bilirubin =1.5 x ULN
- •f. Calculated creatinine clearance using the Cockcroft and Gault equation >50 mL/min
- •9. QTc interval of > 470 ms (for women) and > 450 ms (for men) on the ECG at baseline calculated by either the Fridericia or Framingham formula.
- •10. Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures is required.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •Subjects are excluded from this study if any of the following conditions are met:
- •1. When results of germline or somatic testing done prior to screening are known, subjects known to have mutations of the BRCA1/2 (Breast
- •Cancer gene). If not done previously as standard of care, testing for mutated BRCA 1/ 2 genes may be initiated at the discretion of the site Investigator, and in parallel, screening and treatment may proceed before the results are known.
- •2. Concomitant metformin administration. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic medications are allowed).
- •3. Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia [-6.0 diopters or approximately 20/500], eye surgery <6 months prior to C1D1, or history of a severe eye injury). Subjects with findings of retinopathy on baseline ophthalmology exams will be excluded.
- •4. Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
- •5. Medical or psychiatric conditions that compromise the subject’s ability to give informed consent or to complete the protocol or a history of non-compliance.
- •6. Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma.
- •7. Symptomatic CNS malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
- •8. Serum albumin <30 g/L (3.0 g/dL).
- •9. Deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event that occurs during screening. Subjects with events that occurred prior to screening and are on stable therapy are not excluded.
- •10. Presence of known active bacterial, fungal, or viral infection requiring systemic therapy.
- •11. Known active infection with human immunodeficiency virus (HIV), hepatitis B or C.
- •12. Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction.
- •13. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV.
- •14. Pregnant or lactating.
- •15. Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- •16. Known hypersensitivity to any component of study drug treatments.
- •17. Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug. Participation in observational trials is not excluded.
- •18. History of hydroxychloroquine use (Plaquenil® and other brand names) within the last 12 months prior to dosing of SBP-101.
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