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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
oral capsule
Rabin Medical Center Institute of Oncology
Petah Tikva, Israel
RECRUITINGAdverse 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 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)
Time frame: Every 2 weeks, assessed up to 1 year
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 year
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 year
Disease control rate
clinical activity measure of disease control rate (DCR)
Time frame: Every 8 weeks, assessed up to 1 year
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 year
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Overall survival
clinical activity measure of overall survival (OS), including death from any cause
Time frame: Every 8 weeks, assessed up to 1 year