Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name CLARINET

NCTNCT00353496Other id2-55-52030-726Other id2005-004904-35Other id2005

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 264 participants (actual)
Sponsor: Ipsen · Industry
Design: Randomized · Double masking
Countries: 15 countries
United States, Austria, Belgium, Czechia, Denmark, France, Germany, India, Italy, Netherlands, Poland, Slovakia, Spain, Sweden, United Kingdom
Start: Jun 2006
Primary completion: Apr 2013
Completion: Apr 2013
First posted: 18 Jul 2006 (estimated)
Last update posted: 5 Mar 2025
Conditions: Endocrine Tumors

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062008201020122014

Ph 3
CLARINET
NCT00353496
Jun 2006 to Apr 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

lanreotide (Autogel formulation)Drug
PlaceboDrug

Arms2

Experimental
lanreotide (Autogel formulation)
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Progression-Free Survival (PFS)
Time frame · 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
Registry description
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

Secondary outcomes(5)

Percentage of Patients Alive & Without Disease Progression
Time frame · Week 48 & 96
Registry description
Percentage of patients still ongoing (or completing at Week 96) without centrally assessed disease progression or death at Weeks 48 and 96.
Pharmacokinetic Profile of Lanreotide
Time frame · Week 4, 12, 24, 36, 48, 72, 96
Registry description
Pharmacokinetic Profile of Lanreotide assessed by mean serum concentration at specified timepoints
Change in the Global Health Status Quality of Life Assessment
Time frame · Week 12 to Week 96 (last visit)
Registry description
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.
Percentage of Patients With a Greater Than or Equal to 50% Decrease in Plasma Chromogranin A (CgA) Levels
Time frame · Week 12 to Week 96 (last visit)
Percentage of Patients Still Alive Based on Available Overall Survival Data
Time frame · Randomisation to death or last visit, up to 321 weeks
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 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

Progression-Free Survival (PFS)

Group	Value (Weeks)
Lanreotide (Autogel Formulation)	NA
Placebo	72

Secondary and other outcome results(5)

Secondary outcomeNumber· Week 48 & 96

Percentage of Patients Alive & Without Disease Progression

Group	Value (Percentage of participants)
Lanreotide (Autogel Formulation)	66
Placebo	49

Secondary outcomeMean· Week 4, 12, 24, 36, 48, 72, 96

Pharmacokinetic Profile of Lanreotide

Group	Value (ng/mL)	Spread
Lanreotide (Autogel Formulation)	2.5	0.46

Secondary outcomeLeast squares mean· Week 12 to Week 96 (last visit)

Change in the Global Health Status Quality of Life Assessment

Group	Value (score on a scale)	Spread
Lanreotide (Autogel Formulation)	-5.2	3.7
Placebo	-4.9	3.7

Secondary outcomeNumber· 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

Group	Value (percentage of participants)
Lanreotide (Autogel Formulation)	42.2
Placebo	4.7

Secondary outcomeNumber· Randomisation to death or last visit, up to 321 weeks

Percentage of Patients Still Alive Based on Available Overall Survival Data

Group	Value (percentage of participants)
Lanreotide (Autogel Formulation)	84
Placebo	77

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lanreotide (Autogel Formulation)120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	–	25 / 101	88 / 101
PlaceboSaline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.	–	32 / 103	92 / 103

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

Studies3

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

Download PDF See results (4)

Indexing hint: Randomized controlled trial · 2014

6 results

Lanreotide in metastatic enteropancreatic neuroendocrine tumors.

Caplin et al. 2014The New England journal of medicinecited by 1,288

PMID 25014687DOI 10.1056/nejmoa1316158PUB-25014687

Rights unknown6 results

Source link See results (6)

More studies

1 study on this page

Indexing hint: Case report · 2014

Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel(®): a case report.

Lybaert et al. 2014Case reports in oncologycited by 2

PMID 25408662PMC4224256DOI 10.1159/000368207PUB-25408662

Free to read · publisher termsCC BY-NC

Read at source

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.