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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT00326469 (opens ClinicalTrials.gov in a new tab)Other idA-92-52030-166Other id2004-002871-18Other id2004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
30 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Spain

Start
May 2006
Primary completion
Nov 2009
Completion
Nov 2009
First posted
16 May 2006 (estimated)
Last update posted
5 Nov 2020
Conditions
Neuroendocrine Tumours

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007200820092010
  1. Ph 2

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

    NCT00326469

    May 2006 to Nov 2009

Registry summary

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

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

  • lanreotide (Autogel formulation)Drug

Arms1

  • Experimental

    1

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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(3)

  1. 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

  2. Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel

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

  3. Tolerance

    Time frame · All visits

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2013

8 results

Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study.

Martín-Richard et al. 2013BMC cancercited by 55

PMID 24053191PMC3853091DOI 10.1186/1471-2407-13-427PUB-24053191

CC BY8 results
Download PDFSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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