Namodenoson Treatment of Advanced Pancreatic Cancer

NCT06387342 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CF102-222PC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Assessments of adverse events (AEs) will include characterization of type, incidence, severity (graded by CTCAE v5.0), seriousness, and relationship to treatment.

  Every 2 weeks, assessed up to 1 year

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline

  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), which is a scale of functioning, from 0 (normal activity) to 5 (death)

  Every 2 weeks, assessed up to 1 year

Secondary Outcomes (5)

• Objective response rate

  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

• Duration of response

  Every 8 weeks, assessed up to 1 year

• Overall survival

  Every 8 weeks, assessed up to 1 year

Other Outcomes (7)

• Quality of Life evaluation with EORTC QLQ-C30

  Every 4 weeks, assessed up to 1 year

• Quality of Life evaluation with EORTC QLQ-PAN26

  Every 4 weeks, assessed up to 1 year

• Pharmacokinetics of namodenoson: Cmax

  Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1

Study Arms (1)

Namodenoson 25 mg

EXPERIMENTAL

namodenoson capsule, 25 mg, administered orally, twice daily for consecutive 28-day cycles

Drug: Namodenoson 25mg

Interventions

Namodenoson 25mg DRUG

oral capsule

Also known as: CF102

Namodenoson 25 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 v1.1.
• 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 ≤ 2.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (1)

Rabin Medical Center Institute of Oncology

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (6)

• 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.

  PMID: 26206252 BACKGROUND

• 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.

  PMID: 34750517 BACKGROUND

• 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.

  PMID: 19097774 BACKGROUND

• 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.

  PMID: 38002266 BACKGROUND

• 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.

  PMID: 28052758 BACKGROUND

• 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.

  PMID: 7165009 BACKGROUND

Related Links

• American Heart Association Classes of Heart Failure. www.heart.org.

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

2-chloro-N(6)-(3-iodobenzyl)adenosine-5'-N-methyluronamide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma

  STUDY DIRECTOR

• Salomon M Stemmer, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zivit Harpaz

CONTACT

+972 3 924 1114; Zivit@canfite.co.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label study

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 29, 2024
• Study Start: November 10, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)