Current partner codePEPTIDESDE
NCT00353496·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

264

Locations

71

Results

Posted

Publications

3

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

lanreotide (Autogel formulation)

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

DRUG

Placebo

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

Timeline

From registration to results.

  1. First posted

    Jul 18, 2006

  2. Study start

    Jun 2006

  3. Primary completion

    Apr 2013

  4. Study completion

    Apr 2013

  5. Results posted

    Feb 18, 2015

  6. Registry updated

    Mar 5, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

Percentage of Patients Alive & Without Disease Progression

Time frame · Week 48 & 96

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

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)

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

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

71 registered sites.

Austria · Belgium · Czechia · Denmark · France · Germany · India · Italy · Netherlands · Poland · Slovakia · Spain · Sweden · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, United States

University of Iowa

Iowa City, Iowa, United States

The John Hopkins Hospital

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

University Hospital

Vienna, Austria

UZ Antwerpen

Antwerp, Belgium

UCL Saint Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

Fakultni nemocnice Na

Bulovce, Prague, Czechia

Fekultni nemocnice Olomouc

Olomouc, Czechia

General faculty

Prague, Czechia

Sygehus Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Hôpital A. Paré

Boulogne-Billancourt, France

Hôpital Beaujon

Clichy, France

CAC Oscar Lambret

Lille, France

Hôpital Edouard Herriot

Lyon, France

CHU la Timone

Marseille, France

Hôpital R. Debré

Reims, France

CHI Frejus St Raphael

Saint-Raphaël, France

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.