Namodenoson Treatment of Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCan-Fite BioPharma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Namodenoson 25mg
Drugoral capsule
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Namodenoson 25 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Every 2 weeks, assessed up to 1 year2
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)
Time frame
Every 2 weeks, assessed up to 1 yearSecondary outcomes
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)
Time frame
Every 8 weeks, assessed up to 1 year2
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)
Time frame
Every 8 weeks, assessed up to 1 year3
Disease control rate
clinical activity measure of disease control rate (DCR)
Time frame
Every 8 weeks, assessed up to 1 year4
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
Time frame
Every 8 weeks, assessed up to 1 yearOther outcomes
1
Quality of Life evaluation with EORTC QLQ-C30
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
Time frame
Every 4 weeks, assessed up to 1 year2
Quality of Life evaluation with EORTC QLQ-PAN26
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
Time frame
Every 4 weeks, assessed up to 1 year3
Pharmacokinetics of namodenoson: Cmax
Maximum plasma concentration of namodenoson
Time frame
Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 14
Pharmacokinetics of namodenoson: Cmin
Minimum plasma concentration of namodenoson
Time frame
Cycle 1, day 1 (each cycle is 28 days); Cycle 1, day 15, and Cycle 2, day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov