NL-OMON56480尚未招募2 期
A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma - AMP-270
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects will be eligible for enrollment in the study only if they meet ALL the
- •following criteria at time of Screening:
- •1. Histological diagnosis of pancreatic adenocarcinoma confirmed
- •pathologically: Unresectable pancreatic cancer; locally advanced pancreatic
- •2. Measurable disease per RECIST v.1.1.
- •3. Completion of at least four (4) months of first line FOLFIRINOX treatment
- •and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography
- •(CT) or Magnetic Resonance Imaging (MRI) scan 4 to 6 weeks after last
- •FOLFIRINOX treatment.
- •4. Male or non-pregnant, non-lactating female, >=18 years or age.
- •5. Negative pregnancy test for female subjects. Women of child-bearing
- •potential (WOCBP) and Women not of child-bearing potential are eligible to
- •participate. Both women of child-bearing potential and women of
- •non-child-bearing potential should use an approved method of birth control and
- •agrees to continue to use this method for the duration of the study and for 90
- •days after last treatment.
- •Acceptable methods of contraception include abstinence, female
- •subject/partner*s use of hormonal contraceptive (oral, implanted, or injected)
- •in conjunction with a barrier method (WOCBP only), female subject/partner*s use
- •of an intrauterine device (IUD), or if the female subject/partner is surgically
- •sterile or two years post-menopausal. All male subjects/partners must agree to
- •use a condom consistently and correctly for the duration of the study and for
- •90 days after last treatment. In addition, subjects may not donate sperm for
- •the duration of the study and for 90 days after last treatment.
- •Females who are less than two (2) years post-menopausal, those with tubal
- •ligations and those using contraception must have a negative serum pregnancy
- •test at baseline within the one (1) week prior to the first study medication
- •infusion. Every six weeks, and at study termination a pregnancy test should be
- •performed, either serum or urine stick test. However, if the urine result is
- •positive, a serum pregnancy test will be performed.
- •Any pregnancy that occurs while taking Ampligen® should be recorded using a
- •Pregnancy Report Form and reported immediately to AIM ImmunoTech, Inc.
- •6. Provide signed written informed consent and willingness, ability to comply
- •with study requirements.
- •7. Minimum weight of 40kg at baseline.
- •8. Karnofsky Performance Status of 80 or higher at baseline.
- •9. Subject must have a projected life expectancy of >= 3 months in the opinion
- •of the Investigator.
- •10. Subject has adequate organ function by the following laboratory assessments
- •at baseline (obtained <= 28 days prior to V2 / First treatment):
- •Hematologic
- •Platelets >= 100×109/L
- •Hemoglobin >= 9.0 g/dL
- •Absolute Neutrophil Count (ANC) >= 1.5×109/L
- •Absolute lymphocyte count >= 3 x 109/L
- •AST/ALT <= 3×ULN (if liver metastases are present, <= 5×ULN)
- •Alkaline phosphatase <= 2.0×ULN (if liver metastases are present, <= 5×ULN)
- •Total bilirubin <= 1.5×ULN
- •Albumin >= 3.0 g/dL
- •Creatinine clearance >= 60 mL/min using the Cockcroft-Gault formula. .
- 另有 2 项未显示
排除标准
- •meeting ANY of the following criteria at time of Screening will be excluded
- •from enrollment:
- •1. Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e.,
- •lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or
- •cystadenocarcinoma.
- •2. Subjects who have surgically resectable locally advanced pancreatic
- •adenocarcinoma following treatment with FOLFIRINOX.
- •3. Subject has received prior treatment with Ampligen®.
- •4. Therapy with investigational drugs within 6 weeks of beginning study
- •medication.
- •5. History of prior malignancy, except for adequately treated in situ cancer,
- •basal cell, squamous cell skin cancer, or other cancers (e.g., breast,
- •prostate) for which the subject has been disease-free for at least 3 years.
- •Subjects with prior cancer that is adequately controlled per the judgement of
- •the Investigator will not be excluded from the study.
- •6. Any serious medical condition, laboratory abnormality, psychiatric illness,
- •or comorbidity that, in the judgment of the Investigator, would make the
- •subject inappropriate for the study.
- •7. Serious systemic fungal, bacterial, viral, or other infection that is not
- •controlled or requires intravenous (IV) treatment for infection(s).
- •8. Known history of positivity (regardless of immune status) for human
- •immunodeficiency virus (HIV).
- •9. Known history of, chronic active, or active viral hepatitis A, B, or C
- •10. Clinically significant bleeding within 2 weeks prior to Randomization
- •(e.g., gastrointestinal [GI] bleeding, intracranial hemorrhage).
- •11. Pregnant or lactating women.
- •12. Myocardial infarction within the last 6 months prior to Randomization,
- •symptomatic congestive heart failure (New York Heart Association Classification
- •> Class II), unstable angina, or unstable cardiac arrhythmia requiring
- •medication.
- •13. Subjects with abnormal electrocardiogram (ECG) at baseline QTc interval
- •>470 ms. Both Bazett*s and Fridericia*s corrections need to be applied; if
- •either is >470 ms; subject is not eligible.
- •14. Subjects with positive germline BRCA (gBRCA) mutations.
- •15. Clinically significant ascites defined as requiring >= 1 paracentesis every
- •16. Major surgery, defined as any surgical procedure that involves general
- •anesthesia and a significant incision (i.e., larger than what is required for
- •placement of central venous access, percutaneous feeding tube, or biopsy),
- •within 28 days prior to Randomization or anticipated surgery during the study
- •17. Prior history of receiving immune checkpoint inhibitors (anti-CTLA4,
- •anti-PD1, anti-PD- L1).
- •18. Inability to return for scheduled treatment and assessments.
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