A Phase 3 interventional study of lanreotide (Autogel formulation) and Placebo in Endocrine Tumors, sponsored by Ipsen. Completed at 71 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Ipsen · Phase 3, Interventional, and Treatment
The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.
89 studies on the registry are indexed under Endocrine Gland Neoplasms; 24 are open to participants now.
This study's enrollment of 264 is above the median of 45 across 51 interventional studies indexed under Endocrine Gland Neoplasms.
Browse Endocrine Gland Neoplasms studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: lanreotide (Autogel formulation)
Drug: Placebo
120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
Progression-Free Survival (PFS)
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
Time frame: 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
Percentage of Patients Alive & Without Disease Progression
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Time frame: Week 48 & 96
Pharmacokinetic Profile of Lanreotide
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Time frame: Week 4, 12, 24, 36, 48, 72, 96
Change in the Global Health Status Quality of Life Assessment
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.
Time frame: Week 12 to Week 96 (last visit)
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
Time frame: Week 12 to Week 96 (last visit)
Percentage of Patients Still Alive Based on Available Overall Survival Data
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.
Time frame: Randomisation to death or last visit, up to 321 weeks
264 subjects were screened at 48 investigational sites in 14 countries (Austria, Belgium, Czech Republic, Denmark, France, Germany, India, Italy, Poland, Slovakia, Spain, Sweden, United Kingdom and the United States of America). 204 subjects were randomised to receive study treatment in the Intent to treat (ITT) population.
| Milestone | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| Started | 101 | 103 |
| Completed | 85 | 86 |
| Not completed | 16 | 17 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Protocol violation | 2 | 2 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Physician decision | 6 | 9 |
| Withdrew: Not otherwise specified | 4 | 2 |
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
| Weeks | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| Progression-Free Survival (PFS) | NA (NA to NA) | 72 (48.6 to 96.0) |
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
| Percentage of participants | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| Week 48 | 66 | 49 |
| Week 96 | 53 | 25 |
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
| ng/mL | Lanreotide (Autogel Formulation) |
|---|---|
| At Week 4 predose (n=81) | 2.5 ± 0.46 |
| At Week 12 predose (n=87) | 5.0 ± 0.42 |
| At Week 24 predose (n=74) | 6.1 ± 0.44 |
| At Week 36 predose (n=67) | 6.2 ± 0.39 |
| At Week 48 predose (n=62) | 6.6 ± 0.45 |
| At Week 72 predose (n=52) | 6.8 ± 0.44 |
| At Week 96 predose (n=48) | 6.6 ± 0.39 |
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.
| score on a scale | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| Change in the Global Health Status Quality of Life Assessment | -5.2 ± 3.7 | -4.9 ± 3.7 |
| percentage of participants | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels | 42.2 | 4.7 |
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.
| percentage of participants | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| Percentage of Patients Still Alive Based on Available Overall Survival Data | 84 | 77 |
Collected over Total exposure to treatment was 138.0 subject years for lanreotide vs 123.6 subject years for placebo.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lanreotide (Autogel Formulation) | — | 25/101 (24.8%) | 88/101 (87.1%) |
| Placebo | — | 32/103 (31.1%) | 92/103 (89.3%) |
| Event | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| VomitingGastrointestinal disorders | 4/101 | 2/103 |
| AnaemiaBlood and lymphatic system disorders | 3/101 | 0/103 |
| Urinary tract infectionInfections and infestations | 3/101 | 1/103 |
| Confusional statePsychiatric disorders | 0/101 | 3/103 |
| Abdominal pain upperGastrointestinal disorders | 2/101 | 0/103 |
| Hepatic failureHepatobiliary disorders | 2/101 | 0/103 |
| HyperglycaemiaMetabolism and nutrition disorders | 2/101 | 0/103 |
| Intestinal obstructionGastrointestinal disorders | 2/101 | 1/103 |
| Liver abscessInfections and infestations | 2/101 | 0/103 |
| PneumoniaInfections and infestations | 2/101 | 0/103 |
| Event | Lanreotide (Autogel Formulation) | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 35/101 | 37/103 |
| Abdominal painGastrointestinal disorders | 23/101 | 18/103 |
| VomitingGastrointestinal disorders | 17/101 | 10/103 |
| NasopharyngitisInfections and infestations | 9/101 | 17/103 |
| HeadacheNervous system disorders | 16/101 | 11/103 |
| FatigueGeneral disorders | 11/101 | 16/103 |
| CholelithiasisHepatobiliary disorders | 15/101 | 7/103 |
| NauseaGastrointestinal disorders | 15/101 | 13/103 |
| ConstipationGastrointestinal disorders | 11/101 | 14/103 |
| HypertensionVascular disorders | 13/101 | 5/103 |
Analysis based on intent-to-treat (ITT) population comprised of 204 subjects.
| Age, Continuous(years) | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| Mean | 63 ± 10 | 62 ± 11 | 63 ± 11 |
| Sex: Female, Male(Participants) | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| Female | 48 | 49 | 97 |
| Male | 53 | 54 | 107 |
| Race (NIH/OMB)(Participants) | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 5 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 97 | 96 | 193 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Time since diagnosis(months) | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| Mean | 32.6 ± 46.1 | 34.4 ± 41.4 | 33.5 ± 43.7 |
| Neuroendocrine tumour (NET) origin(participants) | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| Pancreas | 42 | 49 | 91 |
| Midgut | 33 | 40 | 73 |
| Hindgut | 11 | 3 | 14 |
| Unknown/Other | 15 | 11 | 26 |
| Chromogranin A(participants) | Lanreotide (Autogel Formulation) | Placebo | Total |
|---|---|---|---|
| ≤1 × ULN | 33 | 34 | 67 |
| 1-2 × ULN | 25 | 18 | 43 |
| >2 × ULN | 41 | 48 | 89 |
| Unknown | 2 | 3 | 5 |
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Ipsen