gastroenteropancreatic neuroendocrine tumors
Conditions
Brief summary
PFS, defined as the time from the date of randomization to the date of the first documented disease progression as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first, as assessed by a Blinded Independent Review Committee (BIRC)
Detailed description
PFS using RECIST 1.1 as assessed by local Investigators, Overall survival, ORR, defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as per RECIST 1.1, DCR, defined as the proportion of patients with best overall response of CR, PR or stable disease (SD) as per RECIST 1.1, Time to response and duration of response as per RECIST 1.1, Average number of injections of octreotide rescue medication per month for each patient during the trial, Total dosage and dose intensity of rescue medication, Octreotide plasma concentrations over time, Correlation between octreotide concentration and other endpoints or measures as appropriate, Proportion of patients/partners declared competent by trial personnel to administer CAM2029 out of those trying, Change from baseline in Quality of Life Questionnaire – Neuroendocrine Carcinoid Module (QLQ-GINET21), Short Form-36 (SF-36), and the global health status/quality of life scale score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30, Treatment Satisfaction Questionnaire for Medication (TSQM) scores over time using all 4 domains of TSQM (effectiveness, side effects, convenience, and global satisfaction), Adverse events (AEs) (including local tolerability), Changes in laboratory values, vital signs, electrocardiogram readings
Interventions
DRUGSomatuline Autogel 120 mg
DRUGsolution for injection in a pre-filled syringe
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from the date of randomization to the date of the first documented disease progression as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first, as assessed by a Blinded Independent Review Committee (BIRC) | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS using RECIST 1.1 as assessed by local Investigators, Overall survival, ORR, defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as per RECIST 1.1, DCR, defined as the proportion of patients with best overall response of CR, PR or stable disease (SD) as per RECIST 1.1, Time to response and duration of response as per RECIST 1.1, Average number of injections of octreotide rescue medication per month for each patient during the trial, Total dosage and dose intensity of rescue medication, Octreotide plasma concentrations over time, Correlation between octreotide concentration and other endpoints or measures as appropriate, Proportion of patients/partners declared competent by trial personnel to administer CAM2029 out of those trying, Change from baseline in Quality of Life Questionnaire – Neuroendocrine Carcinoid Module (QLQ-GINET21), Short Form-36 (SF-36), and the global health status/quality of life scale score of the Eu | — |
Countries
Belgium, France, Germany, Hungary, Italy, Netherlands, Romania, Spain
Outcome results
None listed