Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-11-10
2026-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial for Advanced or Metastatic Pancreatic Cancer
NCT06255912
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine Hydrochloride With or Without WEE1 Inhibitor AZD1775 in Treating Patients With Previously Untreated Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT02194829
Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
NCT06069778
Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
NCT02754726
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT04233866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Namodenoson 25 mg
namodenoson capsule, 25 mg, administered orally, twice daily for consecutive 28-day cycles
Namodenoson 25mg
oral capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Namodenoson 25mg
oral capsule
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. Pancreatic adenocarcinoma is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.
4. Pancreatic adenocarcinoma has progressed on at least 1 prior systemic treatment regimen, or the patient refuses standard treatment.
5. Prior pancreatic adenocarcinoma treatment was discontinued for at least 14 days prior to the Baseline Visit.
6. Measurable or evaluable disease by RECIST v1.1.
7. 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.
8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2.
9. 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.
10. Life expectancy of ≥8 weeks.
11. For women of childbearing potential, negative serum pregnancy test result.
12. Provide written informed consent to participate.
13. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures
Exclusion Criteria
2. Persistent toxicity ≥Grade 2 from previous cancer therapy, with the exceptions of alopecia and Grade 3 peripheral neuropathy.
3. Major surgery or radiation therapy within 14 days prior to the Baseline Visit.
4. Use of any investigational agent within the shorter of 4 weeks or 5 half-lives prior to the Baseline Visit.
5. 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.
6. Unable to swallow orally administered medication or presence of a gastrointestinal disorder likely to interfere with absorption of the study medication.
7. Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.
8. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.
9. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness or other immunodeficiency.
10. Active second primary malignancy (other than pancreatic adenocarcinoma) requiring treatment.
11. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).
12. 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.
13. 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).
14. Pregnant or lactating female.
15. 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.
16. 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.
17. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Can-Fite BioPharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael H Silverman, MD
Role: STUDY_DIRECTOR
Can-Fite BioPharma
Salomon M Stemmer, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rabin Medical Center Institute of Oncology
Petah Tikva, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Salomon M Stemmer, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Modi S, Kir D, Banerjee S, Saluja A. Control of Apoptosis in Treatment and Biology of Pancreatic Cancer. J Cell Biochem. 2016 Feb;117(2):279-88. doi: 10.1002/jcb.25284.
Mazziotta C, Rotondo JC, Lanzillotti C, Campione G, Martini F, Tognon M. Cancer biology and molecular genetics of A3 adenosine receptor. Oncogene. 2022 Jan;41(3):301-308. doi: 10.1038/s41388-021-02090-z. Epub 2021 Nov 8.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Itzhak I, Bareket-Samish A, Fishman P. Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/beta-catenin, NF-kappaB, and RAS Signaling Pathways. Biomolecules. 2023 Oct 27;13(11):1584. doi: 10.3390/biom13111584.
Li L, Mo FK, Chan SL, Hui EP, Tang NS, Koh J, Leung LK, Poon AN, Hui J, Chu CM, Lee KF, Ma BB, Lai PB, Chan AT, Yu SC, Yeo W. Prognostic values of EORTC QLQ-C30 and QLQ-HCC18 index-scores in patients with hepatocellular carcinoma - clinical application of health-related quality-of-life data. BMC Cancer. 2017 Jan 4;17(1):8. doi: 10.1186/s12885-016-2995-5.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
Related Links
Access external resources that provide additional context or updates about the study.
American Heart Association Classes of Heart Failure. www.heart.org.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CF102-222PC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.