EUCTR2017-001470-42-GB进行中（未招募）1 期
A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously with Gemcitabine as 2nd/3rdline therapy in Advanced Pancreatic Cancer Patients - Berg LLC; BPM31510IV-05
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BERG, LLC
- 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
- •Patients must meet the following criteria in order to be included in the clinical trial:
- •1. The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
- •2. The patient has received:
- •at least one but no more than 2, prior standard or experimental therapies for metastatic pancreatic cancer*. If the patient has had prior gemcitabine treatment, the last date of gemcitabine administration-should be = 28 days prior to receiving study treatment. All patients who have previously received gemcitabine should be discussed with the medical monitor during screening.
- •3. The patient is at least 18 years old.
- •4. The patient has an ECOG performance status 0 - 1
- •5. Measurable tumour lesions according to RECIST 1.1 criteria
- •6. In the opinion of the Investigator, the patient has a life expectancy of > 3 months.
- •7. Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study
- •8. Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
- •9. The patient has adequate organ and marrow function as follows:
- •ANC = 1500 mm3, platelets = 100,000/mm3, hemoglobin = 9 g/dL,
- •serum creatinine =upper limit of normal (ULN) or calculated creatinine clearance > 50 ml/min;
- •10. Total bilirubin = 1.5 X ULN(unless related to Gilbert’s Syndrome); alanine aminotransferase (ALT), aspartate transaminase (AST) = 2.5 times the upper limit of normal (ULN) if no liver involvement or = 5 times the upper limit of normal with liver involvement.
- •11. The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
- •12. The patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) = 1.5 times the upper limit of normal (ULN),
- •13. In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and has signed the informed consent document.
- •*For the purposes of this study, patients who have received at least one,
- •but no more than 2, prior standard therapies for locally advanced
- •pancreatic cancer and then transition to a diagnosis of metastatic
- •pancreatic cancer = 6 months post therapy may count the treatment for
- •locally advanced cancer as 1st line treatment for metastatic cancer.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 73
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •The patient will be excluded from study participation if any of the following criteria are met:
- •1. The patient has uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •2. The patient has active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV)
- •3. The patient has received chemotherapy within 2 weeks or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug. The patient must have recovered from treatment related toxicities to Grade 1 or less (other than alopecia).
- •4. Patients previously treated with gemcitabine: who discontinued gemcitabine due to toxicity in the first 6 weeks of prior treatment or is/was unable to tolerate a dose of 800 mg/m2 weekly at any point due to toxicity are not eligible.
- •5. The patient has received radiation to = 25% of his or her bone marrow within 4 weeks of the first dose of study drug.
- •6. The patient has received an investigational drug within 30 days of the first dose of study drug.
- •7. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- •8. History of other malignancies (except adequately treated Stage 1 cancer, cured basal cell carcinoma, superficial bladder cancer, breast ductal carcinoma in situ (DCIS) without invasive component, or carcinoma in situ of the cervix) unless documented free of cancer for =5 years.
- •9. The patient has not recovered to grade = 1 from adverse events (AEs) due to investigational drugs or other medications, which were administered more than 4 weeks prior to the first dose of study drug.
- •10. The patient is pregnant or lactating.
- •11. The patient is known to be positive for the human immunodeficiency virus (HIV). The effect of BPM31510 on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.
- •12. The patient has an inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
- •13. The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids.
- •14. The patient has uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding.
- •15. The patient has a known predisposition for bleeding such as von Willebrand’s disease or other such condition.
- •16. The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
研究者
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