Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
Conditions
Brief summary
Phase II Part of the Study: Progression Free Survival (PFS), Phase II Part of the Study: Safety in the general study population, Phase III Part of the Study: Overall Survival (OS) in the general study population.
Detailed description
Phase II Part of the Study: •Disease control rate (DCR) in the general study population, Phase II Part of the Study: •Objective response rate (ORR) in the general study population, Phase III Part of the Study: •PFS in the general study population, Phase III Part of the Study: •ORR and DCR in the general study population, Phase III Part of the Study: •OS, PFS, ORR and DCR in the predefined biomarker positive population, Phase III Part of the Study: •Safety, Phase III Part of the Study: •Quality of Life
Interventions
Sponsors
1globe Health Institute LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II Part of the Study: Progression Free Survival (PFS), Phase II Part of the Study: Safety in the general study population, Phase III Part of the Study: Overall Survival (OS) in the general study population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II Part of the Study: •Disease control rate (DCR) in the general study population, Phase II Part of the Study: •Objective response rate (ORR) in the general study population, Phase III Part of the Study: •PFS in the general study population, Phase III Part of the Study: •ORR and DCR in the general study population, Phase III Part of the Study: •OS, PFS, ORR and DCR in the predefined biomarker positive population, Phase III Part of the Study: •Safety, Phase III Part of the Study: •Quality of Life | — |
Countries
France, Spain
Outcome results
None listed