Actively Recruiting
Namodenoson Treatment of Advanced Pancreatic Cancer
Led by Can-Fite BioPharma · Updated on 2025-01-31
20
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Namodenoson Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older
- Histologically or cytologically confirmed pancreatic adenocarcinoma, or clinical diagnosis based on scans and Cancer Antigen 19-9 over 1000 U/mL
- Advanced pancreatic adenocarcinoma that is treatment-refractory or metastatic and not curable with standard therapies
- Disease progression after at least one prior systemic treatment regimen or refusal of standard treatment
- Prior pancreatic cancer treatment stopped at least 14 days before baseline visit
- Measurable or evaluable disease according to RECIST v1.1
- Patients with treated central nervous system metastases meeting specific stability criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Specific laboratory values within required limits before first dose, including neutrophil count, platelet count, kidney function, liver enzymes, bilirubin, and albumin
- Life expectancy of at least 8 weeks
- Negative pregnancy test for women of childbearing potential
- Signed informed consent
- Willingness to follow scheduled visits and trial procedures
You will not qualify if you...
- Receiving systemic cancer therapy within 14 days prior to baseline or during the trial
- Persistent toxicity grade 2 or higher from previous cancer therapy except alopecia and grade 3 peripheral neuropathy
- Major surgery or radiation therapy within 14 days prior to baseline
- Use of investigational agents within 4 weeks or 5 half-lives before baseline
- Use of certain medications that interfere with study drug absorption unless timed properly
- Inability to swallow oral medication or gastrointestinal disorders interfering with drug absorption
- Uncontrolled or unstable thyroid disease
- Active bacterial, viral, or fungal infection needing treatment
- Known HIV/AIDS or other immunodeficiencies
- Active second primary cancer requiring treatment other than pancreatic adenocarcinoma
- Uncontrolled high blood pressure or severe heart failure
- Recent serious cardiovascular events within 1 month before study drug start
- History or ongoing serious cardiac arrhythmias or prolonged QTc interval
- Pregnant or breastfeeding females
- Women of childbearing potential not agreeing to use dual contraception
- Men with partners of childbearing potential not agreeing to use dual contraception
- Any severe or chronic medical or psychiatric condition that may increase risk or interfere with trial participation or results interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rabin Medical Center Institute of Oncology
Petah Tikva, Israel, 49100
Actively Recruiting
Research Team
Z
Zivit Harpaz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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