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Pancreatic AdenocarcinomaPhase 2NCT06387342

Namodenoson Treatment of Advanced Pancreatic Cancer

A Phase 2 study testing Namodenoson 25mg in people with Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Can-Fite BioPharma at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma, Pancreatic Cancer
What is being tested?
Namodenoson 25mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIsrael
Study dates
10 Nov 2024to 15 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zivit Harpaz contact

+972 3 924 1114

Zivit@canfite.co.il

Israel1 site, 1 recruiting

  • Rabin Medical Center Institute of Oncology

    Petah Tikva, 49100

    Salomon M Stemmer, MD

    Recruiting

Other trials in Israel

About this study

Official title: CF102-222PC: A Phase 2 Open-Label Study of the Safety and Activity of Namodenoson in the Treatment of Advanced Pancreatic Adenocarcinoma

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.

Read the detailed description

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.

Being tested
Namodenoson 25mg
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Namodenoson 25mgDrug

    Also called CF102

    oral capsule

Study groups in NCT06387342
Study groupRoleWhat they receive
Namodenoson 25 mgExperimentalnamodenoson capsule, 25 mg, administered orally, twice daily for consecutive 28-day cycles
Receives: Drug: Namodenoson 25mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

    Measured: Every 2 weeks, assessed up to 1 year

  2. 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)

    Measured: Every 2 weeks, assessed up to 1 year

Secondary outcomes (5)

  1. Objective response rate

    clinical activity measure of objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), measured by computed tomography (CT) scan, positron emission tomography (PET) CT, and/or magnetic resonance imaging (MRI)

    Measured: Every 8 weeks, assessed up to 1 year

  2. Progression free survival

    clinical activity measure of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), measured by computed tomography (CT) scan, positron emission tomography (PET) CT, and/or magnetic resonance imaging (MRI)

    Measured: Every 8 weeks, assessed up to 1 year

  3. Disease control rate

    clinical activity measure of disease control rate (DCR)

    Measured: Every 8 weeks, assessed up to 1 year

  4. Duration of response

    clinical activity measure of duration of response (DoR), defined as the time from first response to disease progression or death from any cause, whichever occurs first

    Measured: Every 8 weeks, assessed up to 1 year

  5. Overall survival

    clinical activity measure of overall survival (OS), including death from any cause

    Measured: Every 8 weeks, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start10 Nov 2024
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label study
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06387342
Sponsor's protocol ID
CF102-222PC
Status last verified
Jan 2025
First submitted
15 Apr 2024
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26206252

  • 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.

    PubMed 34750517

  • 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.

    PubMed 19097774

  • 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.

    PubMed 38002266

  • 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.

    PubMed 28052758

  • 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.

    PubMed 7165009

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Namodenoson 25mg in people with Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Can-Fite BioPharma at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zivit Harpaz (+972 3 924 1114, Zivit@canfite.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Every 2 weeks, assessed up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06387342, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.

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