Current partner codePEPTIDESDE
NCT00326469·Phase 2·INTERVENTIONAL

Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours

Status

Completed

Phase

Phase 2

Enrollment

30

Locations

27

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

To evaluate, in patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy at the moment of study inclusion, the efficacy of lanreotide Autogel in tumour growth stabilization.

Interventions

Treatment arms and agents.

DRUG

lanreotide (Autogel formulation)

120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.

Timeline

From registration to results.

  1. First posted

    May 16, 2006

  2. Study start

    May 2006

  3. Primary completion

    Nov 2009

  4. Study completion

    Nov 2009

  5. Results posted

    Not reported

  6. Registry updated

    Nov 5, 2020

Outcomes

What the study measures.

Primary outcomes

Time to disease progression (appearance of 1+ new lesions or increase >or= to 20% of sum of the longest diameters of target lesions compared to the lower sum of maximum diameters recorded since the start of the study).

Time frame · Month 3, 6, 9, 12, 15, 18, 21 and 24

Secondary outcomes

To evaluate efficacy related to tumour's partial or total response, biological disease markers response, symptomatic control, effect of treatment on patient's quality of life

Time frame · Month 3, 6, 9, 12, 15, 18, 21 and 24

Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel

Time frame · Month 3, 6, 9, 12, 18, 21 and 24

Tolerance

Time frame · All visits

Eligibility

Who can take part.

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

Inclusion Criteria: * patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification * patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours) present measurable disease * patients with progressive disease in the previous 6 months before their inclusion in the study * patients with positive IN111 octreotide scintigraphy Exclusion Criteria: * patients with surgically removable localised disease * patients with progressive disease in the first six months of being diagnosed * patients with intestinal obstruction due to a carcinoid tumour * patients who have received treatment with somatostatin analogues during the 6 months before being included in the study * patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned to receive these during the study * patients who have received treatment with liver artery embolisation or radiopharmaceuticals (endoradiotherapy) 12 weeks before being included in the study, or planned during the study.

Study locations

27 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

H. Juan Canalejo

A Coruña, Spain

H. Virgen de los Lirios

Alcoy, Spain

H. General Univ. de Alicante

Alicante, Spain

H. Germans Trias i Pujol

Badalona, Spain

H. Santa Creu i Sant Pau

Barcelona, Spain

H. Clínic i Provincial

Barcelona, Spain

Corporación H. Parc Tauli

Barcelona, Spain

Consorci Sanitari de Terrassa

Barcelona, Spain

H. General de Hospitalet

Barcelona, Spain

H. de Basurto

Bilbao, Spain

H. General de Elche

Elche, Spain

H. de la Princesa

Madrid, Spain

H. Ramón y Cajal

Madrid, Spain

H. Clínico Univ. San Carlos

Madrid, Spain

H. 12 de Octubre

Madrid, Spain

H. Severo Ochoa

Madrid, Spain

Fundación H. Son Llàtzer

Palma de Mallorca, Spain

Consorcio H. de Pontevedre

Pontevedra, Spain

H. de Sagunto

Sagunto, Spain

H. Clínico de Salamanca

Salamanca, Spain

Int. Oncológico San Sebastián

San Sebastián, Spain

H. Univ. de Canarias

Santa Cruz de Tenerife, Spain

H. Marques de Valdecilla

Santander, Spain

Hospital Universitario "Dr. Peset"

Valencia, Spain

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

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