Trial · NCT00353496
Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
NCT00353496, Phase 3, Completed, Ipsen; results first posted 2015-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours. Trials, record NCT00353496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00353496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
- NCT number
- NCT00353496
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 264 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Endocrine Tumors
- Interventions
- lanreotide (Autogel formulation), Placebo
- First posted
- 2006-07-18
- Last updated
- 2025-03-05
- Other registries' IDs
- eudract:2005-004904-35
- Results first posted
- 2015-02-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year | Time from randomization to first documentation of disease progression, or death. Disease progression centrally assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.0 |
| Secondary | Percentage of Patients Alive & Without Disease Progression | Week 48 & 96 | Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96. |
| Secondary | Pharmacokinetic Profile of Lanreotide | Week 4, 12, 24, 36, 48, 72, 96 | Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints |
| Secondary | Change in the Global Health Status Quality of Life Assessment | Week 12 to Week 96 (last visit) | Transformed scores from European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire responses (QLQ)-C30. Questionnaire response scores range from 0 to 100. Higher scores indicate best possible Quality of Life. |
| Secondary | Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels | Week 12 to Week 96 (last visit) | |
| Secondary | Percentage of Patients Still Alive Based on Available Overall Survival Data | Randomisation to death or last visit, up to 321 weeks | Overall survival defined as the time from randomisation to death due to any cause. Subjects were followed for overall survival beyond study completion/withdrawal via annual telephone contact until the last subject completed the study. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year | Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects. | Weeks | MEDIAN |
| SECONDARY | Percentage of Patients Alive & Without Disease Progression | Week 48 & 96 | Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects. | Percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetic Profile of Lanreotide | Week 4, 12, 24, 36, 48, 72, 96 | Analysis based on the intent-to-treat (ITT) population which comprised 101 randomised subjects who received lanreotide | ng/mL | MEAN |
| SECONDARY | Change in the Global Health Status Quality of Life Assessment | Week 12 to Week 96 (last visit) | Analysis based on the intent-to-treat (ITT) population which comprised 193 randomised subjects with valid assessment. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels | Week 12 to Week 96 (last visit) | Analysis based on the subgroup of subjects with an elevated plasma CgA values. Subjects with a gastrinoma were excluded from the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Still Alive Based on Available Overall Survival Data | Randomisation to death or last visit, up to 321 weeks | Analysis based on the intent-to-treat (ITT) population which comprised 204 randomised subjects. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Lanreotide (Autogel Formulation) | NA | 95% Confidence Interval NA to NA | Weeks | |
| Progression-Free Survival (PFS) | Placebo | 72 | 95% Confidence Interval 48.6 to 96.0 | Weeks | |
| Percentage of Patients Alive & Without Disease Progression | Lanreotide (Autogel Formulation) | Week 48 | 66 | Percentage of participants | |
| Percentage of Patients Alive & Without Disease Progression | Placebo | Week 48 | 49 | Percentage of participants | |
| Percentage of Patients Alive & Without Disease Progression | Lanreotide (Autogel Formulation) | Week 96 | 53 | Percentage of participants | |
| Percentage of Patients Alive & Without Disease Progression | Placebo | Week 96 | 25 | Percentage of participants | |
| Pharmacokinetic Profile of Lanreotide | Lanreotide (Autogel Formulation) | At Week 4 predose (n=81) | 2.5 | Standard Deviation 0.46 | ng/mL |
| Pharmacokinetic Profile of Lanreotide | Lanreotide (Autogel Formulation) | At Week 12 predose (n=87) | 5.0 | Standard Deviation 0.42 | ng/mL |
| Pharmacokinetic Profile of Lanreotide | Lanreotide (Autogel Formulation) | At Week 24 predose (n=74) | 6.1 | Standard Deviation 0.44 | ng/mL |
| Pharmacokinetic Profile of Lanreotide | Lanreotide (Autogel Formulation) | At Week 36 predose (n=67) | 6.2 | Standard Deviation 0.39 | ng/mL |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lanreotide (Autogel Formulation) | 101 | |
| Overall Study | STARTED | Placebo | 103 | |
| Overall Study | COMPLETED | Lanreotide (Autogel Formulation) | 85 | |
| Overall Study | COMPLETED | Placebo | 86 | |
| Overall Study | NOT COMPLETED | Lanreotide (Autogel Formulation) | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events226
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 | Abdominal discomfort | Gastrointestinal disorders | Lanreotide (Autogel Formulation) | 5 | 101 | 8 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 3 | 103 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Lanreotide (Autogel Formulation) | 23 | 101 | 32 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 18 | 103 | 34 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lanreotide (Autogel Formulation) | 7 | 101 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 9 | 103 | 15 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Lanreotide (Autogel Formulation) | 5 | 101 | 5 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo | 4 | 103 | 4 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Lanreotide (Autogel Formulation) | 10 | 101 | 15 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 10 | 103 | 11 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanreotide (Autogel Formulation) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lanreotide (Autogel Formulation) | 88 | 101 |
| Total, other adverse events | Placebo | 92 | 103 |
| Total, serious adverse events | Lanreotide (Autogel Formulation) | 25 | 101 |
| Total, serious adverse events | Placebo | 32 | 103 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lanreotide (Autogel Formulation) vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00353496
GET https://conductscience.org/api/trials/v1/NCT00353496/events?page=2