Neuroendocrine TumoursPhase 2NCT00326469
Efficacy and Safety of Lanreotide Autogel in Tumour Stabilization of Patients With Progressive Neuroendocrine Tumours
A Phase 2 study testing lanreotide (Autogel formulation) in people with Neuroendocrine Tumours, run by Ipsen at 27 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumours
- What is being tested?
- lanreotide (Autogel formulation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 27 sitesSpain
- Study dates
- May 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
H. Juan Canalejo
A Coruña, 15006
H. Virgen de los Lirios
Alcoy, 03804
H. General Univ. de Alicante
Alicante, 03010
H. Germans Trias i Pujol
Badalona, 08916
H. Santa Creu i Sant Pau
Barcelona, 08025
H. Clínic i Provincial
Barcelona, 08036
Corporación H. Parc Tauli
Barcelona, 08208
Consorci Sanitari de Terrassa
Barcelona, 08227
H. General de Hospitalet
Barcelona, 08906
H. de Basurto
Bilbao, 48013
H. General de Elche
Elche, 03203
H. de la Princesa
Madrid, 28006
H. Ramón y Cajal
Madrid, 28034
H. Clínico Univ. San Carlos
Madrid, 28040
H. 12 de Octubre
Madrid, 28041
H. Severo Ochoa
Madrid, 28911
Fundación H. Son Llàtzer
Palma de Mallorca, 07198
Consorcio H. de Pontevedre
Pontevedra, 36001
H. de Sagunto
Sagunto, 46520
H. Clínico de Salamanca
Salamanca, 37007
Int. Oncológico San Sebastián
San Sebastián, 20012
H. Univ. de Canarias
Santa Cruz de Tenerife, 38320
H. Marques de Valdecilla
Santander, 39008
Hospital Universitario "Dr. Peset"
Valencia, 446017
H. La Fe
Valencia, 46009
H. Hospital General Universitario de Valencia
Valencia, 46014
H. Miguel Servet
Zaragoza, 50009
About this study
Official title: Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel Administered Every 4 Weeks by Deep Subcutaneous Injection in the Tumour's Growth Stabilization of Patients With Progressive Neuroendocrine Tumours Who Are Not Eligible to be Treated With Either Surgery or Chemotherapy
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.
- Conditions
- Neuroendocrine Tumours
- Being tested
- lanreotide (Autogel formulation)
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanreotide (Autogel formulation)Drug
120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: lanreotide (Autogel formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 3, 6, 9, 12, 15, 18, 21 and 24
Secondary outcomes (3)
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
Measured: Month 3, 6, 9, 12, 15, 18, 21 and 24
Identify tumour growth stabilization predictive factors under treatment with lanreotide Autogel
Measured: Month 3, 6, 9, 12, 18, 21 and 24
Tolerance
Measured: All visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumoursStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326469
- Sponsor's protocol ID
- A-92-52030-166
- Other IDs
- 2004-002871-18, 2004
- Status last verified
- Nov 2020
- First submitted
- 15 May 2006
- Last updated
- 5 Nov 2020
- Results posted
- No
Publications
Martin-Richard M, Massuti B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galan A, Llanos M, Sala MA, Pericay C, Rivera F, Sastre J, Segura A, Quindos M, Maisonobe P; TTD (Tumores del Tracto Digestivo) Study Group. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study. BMC Cancer. 2013 Sep 20;13:427. doi: 10.1186/1471-2407-13-427.
PubMed 24053191
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open, Single Group, Multicentre Study to Evaluate the Efficacy and Safety of Lanreotide Autogel Administered Every 4 Weeks by Deep Subcutaneous Injection in the Tumour's Growth Stabilization of Patients With Progressive Neuroendocrine Tumours Who Are Not Eligible to be Treated With Either Surgery or Chemotherapy
- ClinicalTrials.gov ID
- NCT00326469
- Acronym / sponsor ID
- A-92-52030-166
- Conditions
- Neuroendocrine Tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lanreotide (Autogel formulation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanreotide (Autogel formulation)120mg administered via deep subcutaneous injection every 28 days for up to 24 months or until disease progression. | Drug | 1 |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 24053191Martin-Richard M, Massuti B, Pineda E, Alonso V, Marmol M, Castellano D, Fonseca E, Galan A, Llanos M, Sala MA, Pericay C, Rivera F, Sastre J, Segura A, Quindos M, Maisonobe P; TTD (Tumores del Tracto Digestivo) Study Group. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study. BMC Cancer. 2013 Sep 20;13:427. doi: 10.1186/1471-2407-13-427.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lanreotide (Autogel formulation) in people with Neuroendocrine Tumours, run by Ipsen at 27 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.