Trial · NCT02859064
Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
NCT02859064, Phase 2, Terminated, SCRI Development Innovations, LLC; results first posted 2023-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres. Trials, record NCT02859064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02859064
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
- NCT number
- NCT02859064
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Neuroendocrine Tumors, Gastrointestinal Neoplasms, Carcinoid Tumors
- Interventions
- Lanreotide, Y-90 microspheres
- First posted
- 2016-08-08
- Last updated
- 2023-12-05
- Results first posted
- 2023-07-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | From the day of the first dose to 30 days after the last dose of study medication, up to 52 months | Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03. |
| Secondary | Overall Response Rate | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months | 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. |
| Secondary | Disease Control Rate | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months. | 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. |
| Secondary | Progression Free Survival | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months | 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. |
| Secondary | Overall Survival | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months | The time from Day 1 of study drug administration until death from any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | From the day of the first dose to 30 days after the last dose of study medication, up to 52 months | All enrolled patients who received at least one dose of both study medications, at least one dose of lanreotide and at least one dose of Y-90 microspheres. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months | All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months. | All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months | All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres. | months | MEDIAN |
| SECONDARY | Overall Survival | At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months | All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability | Lanreotide/Y-90 Microspheres | 6 | Participants | ||
| Overall Response Rate | Lanreotide/Y-90 Microspheres | 16.7 | percentage of participants | ||
| Disease Control Rate | Lanreotide/Y-90 Microspheres | 100 | percentage of participants | ||
| Progression Free Survival | Lanreotide/Y-90 Microspheres | 11 | Full Range 3.6 to 51.4 | months | |
| Overall Survival | Lanreotide/Y-90 Microspheres | 11.5 | Full Range 3.7 to 51.4 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lanreotide/Y-90 Microspheres | 6 | |
| Overall Study | COMPLETED | Lanreotide/Y-90 Microspheres | 0 | |
| Overall Study | NOT COMPLETED | Lanreotide/Y-90 Microspheres | 6 |
Source ClinicalTrials.gov
Adverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Acute myocardial infarction | Cardiac disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Cardiac arrest | Cardiac disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Vertigo | Ear and labyrinth disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Macular hole | Eye disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Retinal tear | Eye disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Abdominal distension | Gastrointestinal disorders | Lanreotide/Y-90 Microspheres | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Lanreotide/Y-90 Microspheres | 2 | 6 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Lanreotide/Y-90 Microspheres | 1 | 6 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanreotide/Y-90 Microspheres | 2 | 6 |
| Total, other adverse events | Lanreotide/Y-90 Microspheres | 6 | 6 |
| Total, serious adverse events | Lanreotide/Y-90 Microspheres | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02859064
GET https://conductscience.org/api/trials/v1/NCT02859064/events?page=2