Metastatic Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause.
Detailed description
PFS defined as time until disease progression or death from any cause, whichever occurs first. ORR defined as percentage of subjects with a best overall response of CR or PR, determined using RECIST 1.1 criteria. DCR defined as percentage of subjects with confirmed CR, PR, or SD for at least 16 weeks. DoR in subjects who achieve a CR or PR, defined as time from onset of first CR or PR until disease progression or death from any cause. QoL, assessed using EORTC QLQ-30 and QLQ-PAN26 questionnaires
Interventions
Sponsors
Panbela Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS defined as time until disease progression or death from any cause, whichever occurs first. ORR defined as percentage of subjects with a best overall response of CR or PR, determined using RECIST 1.1 criteria. DCR defined as percentage of subjects with confirmed CR, PR, or SD for at least 16 weeks. DoR in subjects who achieve a CR or PR, defined as time from onset of first CR or PR until disease progression or death from any cause. QoL, assessed using EORTC QLQ-30 and QLQ-PAN26 questionnaires | — |
Countries
Austria, Belgium, France, Germany, Italy, Spain
Outcome results
None listed