Oncology · Phase 3
Lanreotide: CLARINET open-label extension
NCT00842348 ↗ · Extension or follow-up
Related cohort: This extension follows eligible participants from the original CLARINET cohort. It has a separate registration but an overlapping population. Parent study NCT00353496 → · Relationship source ↗
What was tested?
Open-label lanreotide in eligible participants from the CLARINET core trial, including people previously assigned placebo. ↗
Registered primary question: Adverse events throughout the extension; the registry identifies safety as the primary outcome. ↗
What the reviewed report found
Journal year 2021 · Article summary reviewed 2026-09-15
The continuous-treatment group had a reported median progression-free survival of 38.5 months. Adverse-event incidence was lower during extension than during the core study.↗
Keep in context: The reported 38.5-month progression-free survival starts at core-trial randomization, not extension entry. Extension entrants were selected and all received active treatment, so this is not a new randomized long-term comparison. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Different questions use different populations
The extension safety population contained 89 participants: 42 previously assigned lanreotide and 47 placebo. The efficacy analysis retained all participants randomized in the core trial, even if they did not enter the extension; its original groups were 101 and 103. Full text ↗ · Indexed abstract ↗
Sections: Populations and subgroups; Patients and treatment exposure; Efficacy.
The survival clock starts in the core trial
Progression-free survival used time from core randomization to progression or death, appending extension follow-up. The 38.5-month median is not an estimate beginning at extension entry. The paper approximates a month as four weeks. Full text ↗ · Indexed abstract ↗
Sections: Efficacy assessments; Statistical analyses; Efficacy.
Selection and source revisions remain relevant
A post hoc sensitivity analysis addressed eligible core-study completers who did not enter the extension. The paper also states that one core placebo progression event had previously been misclassified and was included in this later analysis. Earlier source versions remain separately attributed. Full text ↗ · Indexed abstract ↗
Sections: Statistical analyses; Efficacy.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 89 · reported actual
- Registry status
- Completed
- Allocation and masking
- Na · Open label
- Design
- Single group
- Eligible ages
- 18 Years; maximum not specified
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2022-10-12; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
CLARINET open-label extension
- Design in the report
- Eligible original-trial participants entered an extension in which everyone received lanreotide.↗
- Participants in the report
- 89 participants entered: 42 previously assigned lanreotide and 47 previously assigned placebo.↗
- Limitations
- Selective extension enrollment, crossover and absence of a concurrent placebo group prevent an independent randomized long-term comparison.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour ↗
Protocol identifier: 2-55-52030-729. Sponsor: Ipsen.
Retrieved 2026-09-20; SHA-256 eacb31476c02241cf3b9aaf49a94a02eee86ccebfb7e5e6889a947c28395c1ba.
PMID 33052555
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. PubmedArticle[MedlineCitation/PMID=33052555] in the retained EFetch batch. SHA-256 0e6795be99af1c93f3a3e2726fc8a17152661ca29e8dead110bff36feb856127.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 965ff6216bbf51d5c511964f6dc349e1756d0980802f50665ca54b21e9fd4f86.
Selected full text: PMC7881960
Retrieved 2026-09-20; SHA-256 2e6405d67f8dff7f445d87c023263c18fe6392aab05e091b0d0c430a635cb08c. Section identifiers and hashes are included in the cited study data.