Primary outcomeNumber· Throughout the study until the completion/early discontinuation visit.
Adverse Events
| Group | Value (participants with any TEAEs) |
|---|---|
| Lanreotide Autogel | 40 |
| Placebo | 46 |
| Total | 86 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataStudy of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
Short name NET729
NCTNCT00842348 (opens ClinicalTrials.gov in a new tab)Other id2-55-52030-729Other id2008-004019-36Other id2008
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 89 participants (actual)
- Sponsor
- Ipsen · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
9 countries
United States, Belgium, Czechia, France, Italy, Poland, Slovakia, Spain, United Kingdom
- Start
- Feb 2009
- Primary completion
- Dec 2015
- Completion
- Dec 2015
- First posted
- 12 Feb 2009 (estimated)
- Last update posted
- 12 Oct 2022
- Conditions
- Non Functioning Entero-pancreatic Endocrine Tumour
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2010201220142016
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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).
Interventions
- lanreotide (Autogel formulation)Drug
Arms1
Experimental
Lanreotide (Autogel formulation)
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).
Primary outcomes1
Outcomes the sponsor listed as primary.
Adverse Events
Time frame · Throughout the study until the completion/early discontinuation visit.
Registry 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.
Secondary outcomes(1)
Progression Free Survival (PFS): Kaplan-Meier Estimate
Time frame · Throughout the study (every 24 weeks and at completion/withdrawal visit)
Registry description
The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours \[RECIST\] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time. Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMedian· Throughout the study (every 24 weeks and at completion/withdrawal visit)
Progression Free Survival (PFS): Kaplan-Meier Estimate
| Group | Value (weeks) |
|---|---|
| Lanreotide Autogel - Randomised Treatment in Study 726 | 154.14 |
| Placebo - Randomised Treatment in Study 726 | 72.00 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lanreotide AutogelPatients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study. | – | 11 / 42 | 34 / 42 |
| PlaceboPatients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study. | – | 14 / 47 | 42 / 47 |
| TotalAll patients treated with lanreotide 120 mg (Autogel formulation) in the open label study. | – | 25 / 89 | 76 / 89 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
PubMed tag: none · 2021
4 results
Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study.
Caplin et al. 2021Endocrinecited by 64
PMID 33052555PMC7881960DOI 10.1007/s12020-020-02475-2PUB-33052555
CC BY4 results
Indexing hint: Clinical trial · 2016
8 results
Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study.
Caplin et al. 2016Endocrine-related cancercited by 176
PMID 26743120PMC4740728DOI 10.1530/erc-15-0490PUB-26743120
CC BY8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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