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Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
Phase 2 trial testing Lanreotide in Neuroendocrine Tumors in 6 participants. Terminated before completion.
| Lead sponsor | SCRI Development Innovations, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 28 July 2017 |
| Primary completion | 27 May 2022 |
| Estimated completion | 10 June 2022 |
| Sites | 3 locations across United States |
SCRI Development Innovations, LLC — full company profile →
18 and older, any sex, with Neuroendocrine Tumors or Gastrointestinal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
| Group | Value | 95% CI |
|---|---|---|
| Lanreotide/Y-90 Microspheres | 6 |
Percentage of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Lanreotide/Y-90 Microspheres | 16.7 |
Percentage of patients with CR, PR or stable disease (SD) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Stable Disease: Meeting neither criteria for PR or Progression (PD= greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions). Disease Control Rate (DCR) = CR + PR + SD.
| Group | Value | 95% CI |
|---|---|---|
| Lanreotide/Y-90 Microspheres | 100 |
The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Per RECIST V1.1 criteria, progression is defined as a greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.
| Group | Value | 95% CI |
|---|---|---|
| Lanreotide/Y-90 Microspheres | 11 | 3.6 – 51.4 |
The time from Day 1 of study drug administration until death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Lanreotide/Y-90 Microspheres | 11.5 | 3.7 – 51.4 |
Time frame: From the date of first dose to 30 days after last dose of study treatment, up to 52 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lanreotide/Y-90 Microspheres |
|---|---|---|
| Asthenia | Musculoskeletal and connective tissue disorders | — |
| Sepsis | Infections and infestations | — |
| Acute Myocardial Infarction | Cardiac disorders | — |
| Cardiac Arrest | Cardiac disorders | — |
| Reaction | System | Lanreotide/Y-90 Microspheres |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
| Macular hole | Eye disorders | — |
| Retinal tear | Eye disorders | — |
| Abdominal discomfort | Gastrointestinal disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Abdominal tenderness | Gastrointestinal disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Diverticulum | Gastrointestinal disorders | — |
| Epigastric discomfort | Gastrointestinal disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Chills | General disorders | — |
| Oedema peripheral | General disorders | — |
| Pyrexia | General disorders | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — |
| Clostridium difficile infection | Infections and infestations | — |
| Gingivitis | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Blood lactic acid increased | Investigations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Hypovolaemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Asthenia, Sepsis, Acute Myocardial Infarction, Cardiac Arrest.
Data from ClinicalTrials.gov NCT02859064 adverse events section.
Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA approval to treat patients with metastatic NETs. The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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