NCT06387342招募中2 期
CF102-222PC: A Phase 2 Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients.
详细描述
All patients will receive the study drug twice daily. The study drug is given as a capsule, orally (by mouth). Patients will be monitored regularly for safety. Tumor imaging will be performed approximately every two months. Patients can decide to stop the treatment with study drug at any time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females at least 18 years of age.
- •Histologically or cytologically confirmed pancreatic adenocarcinoma, or clinically diagnosed based upon scan results and a serum Cancer Antigen 19-9 value >1000 U/mL on at least 1 occasion.
- •Pancreatic adenocarcinoma is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.
- •Pancreatic adenocarcinoma has progressed on at least 1 prior systemic treatment regimen, or the patient refuses standard treatment.
- •Prior pancreatic adenocarcinoma treatment was discontinued for at least 14 days prior to the Baseline Visit.
- •Measurable or evaluable disease by RECIST v1.
- •Patients with a history of treated central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: disease outside the CNS is present; there is no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study; and there is no history of intracranial hemorrhage or spinal cord hemorrhage.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤
- •The following laboratory values must be documented prior to the first dose of study drug:
- •Absolute neutrophil count (ANC) ≥1.5 × 109/L
- •Platelet count ≥50 × 109/L
- •Creatinine clearance ≥50 mL/min (estimated glomerular filtration rate by the Cockcroft-Gault) or serum creatinine ≤2.0 mg/dL
- •Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤10X the upper limit of normal
- •Total bilirubin ≤10 mg/dL
- •Serum albumin ≥2.0 g/dL.
- •Life expectancy of ≥8 weeks.
- •For women of childbearing potential, negative serum pregnancy test result.
- •Provide written informed consent to participate.
- •Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures
排除标准
- •Receipt of systemic cancer therapy within 14 days prior to the Baseline Visit or concurrently during the trial.
- •Persistent toxicity ≥Grade 2 from previous cancer therapy, with the exceptions of alopecia and Grade 3 peripheral neuropathy.
- •Major surgery or radiation therapy within 14 days prior to the Baseline Visit.
- •Use of any investigational agent within the shorter of 4 weeks or 5 half-lives prior to the Baseline Visit.
- •Concomitant use of P-glycoprotein (P-gp)/breast cancer resistance protein (BCRP) inhibitors and/or substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product.
- •Unable to swallow orally administered medication or presence of a gastrointestinal disorder likely to interfere with absorption of the study medication.
- •Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.
- •Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
- •Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness or other immunodeficiency.
- •Active second primary malignancy (other than pancreatic adenocarcinoma) requiring treatment.
- •Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
- •Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 1 month prior to initiation of study drug.
- •History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the corrected QT interval (QTc) (Fridericia) interval to >470 msec [mean of triplicate electrocardiogram measurements] (patients with bundle branch block or a cardiac pacemaker will not be excluded for QTc reasons).
- •Pregnant or lactating female.
- •Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug and for at least 1 month thereafter.
- •Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 1 month afterward.
- •Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and/or with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.
研究组 & 干预措施
Namodenoson 25 mg
Experimental
namodenoson capsule, 25 mg, administered orally, twice daily for consecutive 28-day cycles
干预措施: Namodenoson 25mg (Drug)
结局指标
主要结局
Adverse Events
时间窗: Every 2 weeks, assessed up to 1 year
Assessments of adverse events (AEs) will include characterization of type, incidence, severity (graded by CTCAE v5.0), seriousness, and relationship to treatment.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline
时间窗: Every 2 weeks, assessed up to 1 year
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), which is a scale of functioning, from 0 (normal activity) to 5 (death)
次要结局
- Duration of response(Every 8 weeks, assessed up to 1 year)
- Progression free survival(Every 8 weeks, assessed up to 1 year)
- Disease control rate(Every 8 weeks, assessed up to 1 year)
- Objective response rate(Every 8 weeks, assessed up to 1 year)
- Overall survival(Every 8 weeks, assessed up to 1 year)
研究者
研究点 (1)
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相关资讯
Can-Fite Doses First Patient in Phase IIa Pancreatic Cancer Trial with Namodenoson- Can-Fite BioPharma has dosed the first patient in its Phase IIa clinical trial evaluating Namodenoson for advanced pancreatic adenocarcinoma.
- The open-label, multicenter trial will assess the safety, clinical activity, and pharmacokinetics of oral Namodenoson (25 mg twice daily) in patients who have progressed on first-line therapy.
- The primary objective is to characterize the safety profile of Namodenoson, while secondary objectives include evaluating clinical activity via ORR, PFS, DCR, DoR, and OS.
- Namodenoson, an orally bioavailable A3 adenosine receptor agonist, has received Orphan Drug Designation from the FDA for this indication.last yearCan-Fite BioPharma Doses First Patient in Phase IIa Pancreatic Cancer Trial with Namodenoson- Can-Fite BioPharma has dosed the first patient in its Phase IIa clinical trial (NCT06387342) evaluating Namodenoson for advanced pancreatic adenocarcinoma.
- The open-label, multicenter trial will assess the safety, clinical activity, and pharmacokinetics of oral Namodenoson (25 mg twice daily) in patients who have progressed on first-line therapy.
- The primary objective is to characterize the safety profile of Namodenoson, while secondary objectives include evaluating ORR, PFS, DCR, DoR, and OS.
- Namodenoson has received Orphan Drug Designation from the U.S. FDA for pancreatic cancer, highlighting the unmet need for effective treatments.last yearCan-Fite Doses First Patient in Phase IIa Pancreatic Cancer Trial with Namodenoson- Can-Fite BioPharma has dosed the first patient in a Phase IIa clinical trial evaluating Namodenoson for advanced pancreatic adenocarcinoma.
- The open-label, multicenter trial will assess the safety, clinical activity, and pharmacokinetics of oral Namodenoson in patients who have progressed on first-line therapy.
- The primary objective is to characterize the safety profile of Namodenoson, while secondary objectives include evaluating Objective Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS).
- Namodenoson, an orally bioavailable A3 adenosine receptor agonist, has received Orphan Drug Designation from the FDA for this indication.last yearCan-Fite Receives IRB Approval for Phase IIa Pancreatic Cancer Trial of Namodenoson- Can-Fite BioPharma received Institutional Review Board approval from Rabin Medical Center to initiate a Phase IIa open-label study evaluating Namodenoson in advanced pancreatic adenocarcinoma patients.
- The multicenter trial will enroll approximately 20 patients with disease progression on first-line therapy, administering oral Namodenoson 25 mg twice daily in 28-day cycles.
- Namodenoson demonstrated efficacy in preclinical pancreatic cancer models through deregulation of Wnt/β-catenin, NF-κB, and RAS signaling pathways.
- The A3 adenosine receptor-targeting drug has shown promising results in liver cancer, with one patient achieving complete response lasting over 7 years.2 years ago