Pancreatic Adenocarcinoma, Pancreatic Cancer
Conditions
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.
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.
Interventions
DRUGNamodenoson 25mg
oral capsule
Sponsors
Can-Fite BioPharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females at least 18 years of age. 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
1. Receipt of systemic cancer therapy within 14 days prior to the Baseline Visit or concurrently during the trial. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Every 8 weeks, assessed up to 1 year | 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) |
| Progression free survival | Every 8 weeks, assessed up to 1 year | 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) |
| Disease control rate | Every 8 weeks, assessed up to 1 year | clinical activity measure of disease control rate (DCR) |
| Duration of response | Every 8 weeks, assessed up to 1 year | 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 |
| Overall survival | Every 8 weeks, assessed up to 1 year | clinical activity measure of overall survival (OS), including death from any cause |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life evaluation with EORTC QLQ-C30 | Every 4 weeks, assessed up to 1 year | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), in which summary scores range from 0 to 100, with higher scores indicating better health-related quality of life |
| Pharmacokinetics of namodenoson: Cmax | Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1 | Maximum plasma concentration of namodenoson |
| Quality of Life evaluation with EORTC QLQ-PAN26 | Every 4 weeks, assessed up to 1 year | European Organization for Research and Treatment of Cancer Quality of Life pancreatic adenocarcinoma-specific module, the EORTC QLQ-PAN26, in which summary scores range from 0 to 100, with higher scores indicating better health-related quality of life |
| Pharmacokinetics of namodenoson: Cmin | Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1 | Minimum plasma concentration of namodenoson |
| Pharmacokinetics of namodenoson: AUC(0-12) | Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1 | Area under the curve of namodenoson plasma exposure from 0-12 hours post-dose |
| Cancer antigen 19-9 (CA 19-9) | Every 4 weeks, assessed up to 1 year | Change from baseline in Cancer antigen 19-9 (CA 19-9) biomarker during treatment |
| Carcinoembryonic Antigen (CEA) | Every 4 weeks, assessed up to 1 year | Change from baseline in Carcinoembryonic Antigen (CEA) biomarker during treatment |
Countries
Israel
Contacts
Primary ContactZivit Harpaz
Outcome results
None listed