gastroenteropancreatic neuroendocrine tumors neuroendocrine tumor which started in pancreas or other parts gastrointestinal tract
Conditions
Interventions
Screening Period
The Screening Period will have a duration of up to 28 days. During this period,
eligibility will be evaluated.
Open-label Randomized Treatment Period
Eligible patients will be rand
Sponsors
Camurus AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria for the Trial • Male or female patient >=18 years old • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin • At least 1 measurable, somatostatin receptor-positive*, lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization) *Somatostatin-receptor imaging must be performed within 12 months before randomization. Somatostatin receptor-positive lesions are defined as lesions with a visual assessment of uptake greater than the liver • Results from FDG-PET CT for patients with well-differentiated Grade 3 NET (if performed) must show that FDG avid areas of disease also are avid on somatostatin-receptor imaging • ECOG performance status of 0 to 2 Main Inclusion Criteria for the Extension Treatment Period • Disease progression confirmed by the BIRC • At least 6 months of treatment with IMP (CAM2029/comparator) in the Randomized Treatment Period before documented disease progression
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria for the Trial • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease • Known central nervous system metastases • Consecutive treatment with long-acting SSAs for more than 6 months before randomization • Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of 8.0% • Cardiac history or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following: * History of myocardial infarction, unstable angina pectoris, or coronary artery bypass graft within 6 months before screening * Uncontrolled congestive heart failure • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, or high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II, and third-degree atrioventricular block) • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: * Risk factors for Torsades de Pointes, including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia *Treatment with concomitant medication(s) with a "known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced with safe alternative medication at least 7 days or 5 half-lives (whichever is longer) before start of IMP treatment * Patients with a QTc interval corrected by Fridericia's formula >450 msec for males and >470 msec for females at screening • Any other contraindicated serious medical condition that, in the Investigator's opinion, may prevent the patient from safely participating in the trial Main Exclusion Criteria for the Extension Treatment Period • Unresolved, drug-related serious adverse event that, in the Investigator's opinion, contraindicates treatment with CAM2029 • Clinically significant symptoms, medical conditions, rapid clinical deter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint • 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 |
|---|---|
| Secondary Endpoints • 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 and gallbladder imaging Exploratory Endpoints • Progression-free survival in the Extension Treatment Period (PFS-ext), defined as time from date of randomization to the date of documented disease progression as per RECIST 1.1 or death from any cause, whichever occurs first, in the Open-label Extension Treatment Period, as assessed by a BIRC • PFS2, defined as time from date of randomization to the date of documented progression as per RECIST 1.1 on next-line therapy or death from any cause, whichever occurs first • Num | — |
Countries
Netherlands
Outcome results
None listed