Study Of Lanreotide Autogel In Non-functioning Entero-pancreatic Endocrine Tumours

Study Overview

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours

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.

N/A

Endocrine Tumors

DRUG: lanreotide (Autogel formulation)
DRUG: Placebo

2-55-52030-726
2005-004904-35 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-07-17	Results First Submitted 2015-01-15	Last Update Submitted that met QC Criteria 2025-02-18
First Submitted that Met QC Criteria 2006-07-17	Results First Submitted that Met QC Criteria 2015-02-17	Last Update Posted (ACTUAL) 2025-03-05
First Posted (ACTUAL) 2006-07-18	Results First Posted 2015-02-18	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: lanreotide (Autogel formulation)	DRUG: lanreotide (Autogel formulation) 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
PLACEBO_COMPARATOR: Placebo	DRUG: Placebo Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: lanreotide (Autogel formulation)

DRUG: lanreotide (Autogel formulation)

120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

PLACEBO_COMPARATOR: Placebo

DRUG: Placebo

Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.

Primary Outcome Measures	Measure Description	Time Frame
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	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

Secondary Outcome Measures	Measure Description	Time Frame
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.	Week 48 & 96
Pharmacokinetic Profile of Lanreotide	Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints	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.	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		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.	Randomisation to death or last visit, up to 321 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Endocrine tumour in the intestine or pancreas and with locally advanced or metastatic disease
No hormone related symptoms
Well or moderately differentiated tumour confirmed by histology
Tumour lesions which are measurable by a CT or MRI scan

Previously treated with a somatostatin analogue unless more than 6 months ago and given for no more than 15 days
Treated within the last 6 months with interferon, chemoembolisation or chemotherapy or at any time with a radionuclide
Had a previous cancer except basal cell carcinoma and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for 5 years
Pregnant or lactating
Females must use adequate contraception during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Medical Director, Endocrinology, Ipsen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.
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.
Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel((R)): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.

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Clinical Trial Record