Metastatic refractory Pancreatic Cancer
Conditions
Brief summary
Anti-tumour efficacy of tx will be primarily measured as 12W PFS: Percentage of patients free of progression at 12W from starting treatment into the study as determined by radiographic disease assessments per RECIST version 1.1. Planned efficacy assessments will occur by CT TAP at baseline, 6W, 12W post starting treatment and then q-8 weekly until disease progression or consent withdrawal.
Detailed description
Confirmed tumour response rate and duration of response as assessed by RECIST version 1.1., Overall survival, To evaluate the safety and tolerability of this regimen as measured by incidence of adverse events reported and toxicity evaluation as per the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Interventions
DRUGHydroxychloroquine sulfate Accord 200mg film-coated tablets
Sponsors
Cancer Trials Ireland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-tumour efficacy of tx will be primarily measured as 12W PFS: Percentage of patients free of progression at 12W from starting treatment into the study as determined by radiographic disease assessments per RECIST version 1.1. Planned efficacy assessments will occur by CT TAP at baseline, 6W, 12W post starting treatment and then q-8 weekly until disease progression or consent withdrawal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed tumour response rate and duration of response as assessed by RECIST version 1.1., Overall survival, To evaluate the safety and tolerability of this regimen as measured by incidence of adverse events reported and toxicity evaluation as per the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | — |
Countries
Ireland
Outcome results
None listed