Clinical trial · Interventional
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Functioning Entero-pancreatic Endocrine Tumour | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lanreotide (Autogel formulation)
- description
- Patients from the preceding DB study (Study 726) were treated with open label lanreotide Autogel 120 mg by deep subcutaneous injections every 28 days. Patients were included if they had been treated with lanreotide (Autogel formulation) or placebo in DB Study 726 and had stable disease at the end of the 96-week treatment period, or if they had received placebo and had disease progression at any time during Study 726. Safety data were based on the safety population patients who received lanreotide in Study 729). The main efficacy analysis was based on the ITT population (patients randomised in Study 726 regardless of whether they continued into Study 729).
- interventionNames
- Drug: lanreotide (Autogel formulation)
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- Throughout the study until the completion/early discontinuation visit.
- description
- Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729. An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if: * It was not present prior to receiving the first dose of study treatment in Study 729; or, * It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729. Adverse event data are presented in the AE section.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Had provided written informed consent prior to any study-related procedures. 2. Had been enrolled and treated in Study 2-55-52030-726 and either: * Was stable at 96 weeks of treatment (whatever the treatment received during the 2 years of participation, i.e. no code break at Week 96); or, * Had received at least one injection in Study 2-55-52030-726 and had disease progression, confirmed by central assessment, during the course of the study and code break showed placebo. 3. Had a World Health Organisation (WHO) performance score lower than or equal to 2. Exclusion Criteria: 1. Had been enrolled and treated in the frame of the protocol and had disease progression during the study and the code break showed a treatment with lanreotide Autogel 120 mg. 2. Had received any new treatment for the entero-pancreatic NET since the end of participation in the study. 3. Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET. 4. Had been treated with radionuclide at any time prior to study entry. 5. Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg. 6. Were likely to require treatment during the study with drugs that were not permitted by the study protocol. 7. Were at risk of pregnancy or lactation. Females of childbearing potential had to provide a negative pregnancy test at the start of study and had to be using oral, double barrier or injectable contraception. Non-childbearing potential was defined as postmenopause for at least 1 year, or surgical sterilisation or hysterectomy at least 3 months before the start of the study. 8. Had any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9. Had abnormal findings at Visit 1, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might have jeopardised the patient's safety or decreased the chance of obtaining satisfactory data needed to achieve the objective(s) of the study. 10. Previous enrolment in this study.
References
Publications (2)
- RESULTCaplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P; CLARINET Investigators. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer. 2016 Mar;23(3):191-9. doi: 10.1530/ERC-15-0490. Epub 2016 Jan 7. PMID 26743120
- DERIVEDCaplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14. PMID 33052555