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Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour (NET729)

Primary Purpose

Non Functioning Entero-pancreatic Endocrine Tumour

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lanreotide (Autogel formulation)
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Functioning Entero-pancreatic Endocrine Tumour focused on measuring Lanreotide, Somatuline, Neuroendocrine tumour, NET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cedars-Sinai Outpatient Cancer Center
  • The Johns Hopkins Hospital
  • UZ Antwerpen
  • UCL Saint Luc
  • Fakultni nemocnice Na Bulovce
  • General faculty
  • Hôpital Beaujon
  • CAC Oscar Lambret
  • Hôpital Edouard Herriot
  • Hôpital R. Debré
  • Centro di Refierimiento Oncologica
  • INSCT
  • University of Naples
  • Azienda San Giovanni Battista
  • Centrum Diagnostyczno-Lecznicze "Gammed"
  • Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
  • Narodny onkologicky ustav
  • Hospital Vall d'Hebron
  • Institut Catala Oncologia
  • University Hospital Wales
  • Western General Hospital
  • Beatson West of Scotland Cancer Centre
  • St James Hospital
  • Royal Free Hospital
  • QMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lanreotide (Autogel formulation)

Arm 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).

Outcomes

Primary Outcome Measures

Adverse Events
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 Outcome Measures

Progression Free Survival (PFS): Kaplan-Meier Estimate
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.

Full Information

First Posted
February 11, 2009
Last Updated
September 15, 2022
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00842348
Brief Title
Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour
Acronym
NET729
Official Title
Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
While somatostatin analogue treatment is the primary medical therapy for patients with hormone related symptoms and is indicated for the treatment of hormone related symptoms in many international countries, there is no reference standard medical therapy for asymptomatic patients. A 96-week study (Study 2-55-52030-726 (726), NCT00353496) was conducted to investigate the effect of lanreotide Autogel on progression free survival (PFS) in patients with well or moderately differentiated nonfunctioning enteropancreatic NET. While Study 726 was ongoing, the sponsor considered that therapy with lanreotide Autogel should continue to be an option to patients with stable disease at the end of the 96-week treatment period. This extension study was therefore initiated (Study 2-55-52030-729 (729)) which investigated the long term safety of treatment with lanreotide Autogel and enabled investigators to continue to treat their patients who had stable disease, as well as to treat placebo patients who experienced disease progression during the initial 96-week study (Study 726).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Functioning Entero-pancreatic Endocrine Tumour
Keywords
Lanreotide, Somatuline, Neuroendocrine tumour, NET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanreotide (Autogel formulation)
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
lanreotide (Autogel formulation)
Other Intervention Name(s)
Lanreotide, Lanreotide Autogel, Somatuline, Somatuline Autogel, Somatuline Depot
Intervention Description
Autogel 120 mg
Primary Outcome Measure Information:
Title
Adverse Events
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.
Time Frame
Throughout the study until the completion/early discontinuation visit.
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS): Kaplan-Meier Estimate
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.
Time Frame
Throughout the study (every 24 weeks and at completion/withdrawal visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Had provided written informed consent prior to any study-related procedures. 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. Had a World Health Organisation (WHO) performance score lower than or equal to 2. Exclusion Criteria: 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. Had received any new treatment for the entero-pancreatic NET since the end of participation in the study. Were likely to require any additional concomitant treatment to lanreotide Autogel 120 mg for the entero-pancreatic NET. Had been treated with radionuclide at any time prior to study entry. Had a history of hypersensitivity to drugs with a similar chemical structure to lanreotide Autogel 120 mg. Were likely to require treatment during the study with drugs that were not permitted by the study protocol. 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. 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. 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. Previous enrolment in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Outpatient Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-4606
Country
United States
Facility Name
UZ Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
UCL Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
Fakultni nemocnice Na Bulovce
City
Prague
Country
Czechia
Facility Name
General faculty
City
Praha
Country
Czechia
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
CAC Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital R. Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centro di Refierimiento Oncologica
City
Aviano
Country
Italy
Facility Name
INSCT
City
Milano
Country
Italy
Facility Name
University of Naples
City
Naples
Country
Italy
Facility Name
Azienda San Giovanni Battista
City
Torino
Country
Italy
Facility Name
Centrum Diagnostyczno-Lecznicze "Gammed"
City
Warszawa
Country
Poland
Facility Name
Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny
City
Warszawa
Country
Poland
Facility Name
Narodny onkologicky ustav
City
Bratislava
Country
Slovakia
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Institut Catala Oncologia
City
Barcelona
Country
Spain
Facility Name
University Hospital Wales
City
Cardiff
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
St James Hospital
City
Leeds
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
QMC
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/
Citations:
PubMed Identifier
26743120
Citation
Caplin 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.
Results Reference
result
PubMed Identifier
33052555
Citation
Caplin 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.
Results Reference
derived

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Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero- Pancreatic Endocrine Tumour

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