Summary
EudraCT Number:2004-002871-18
Sponsor's Protocol Code Number:A-92-52030-166
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2006-02-15
Trial results View results
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-002871-18
A.3Full title of the trial
Phase II, open, single group,multicentre study to evaluate the efficacy and safety of Somatuline Autogel® (120 mg) 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
A.4.1Sponsor's protocol code numberA-92-52030-166
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorIPSEN PHARMA, S.A.
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Somatulina Autogel® 120 mg
D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA, S.A.
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNLanreotide
D.3.9.2Current sponsor code52030
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number120
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy
MedDRA Classification
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
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´s inclusion, the efficacy of Somatuline Autogel in tumour´s growth stabilization.
E.2.2Secondary objectives of the trial
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
1. The patient must give written informed consent prior to any study-related procedure. Informed consent must be given in writing except for patients who were unable to do it, in this case witnessed oral informed consent will be accepted.

2. Patients from both genders and over 18 years of age.

3. Patients with histopathologic diagnosis of well-differentiated neuroendocrine tumour or carcinoma according to WHO classification.

4. Patients who, according to RECIST criteria (Response Evaluation Criteria in Solid Tumours), present measurable disease (1).
(1) measurable disease: existence of at least one lesion which can be accurately
measured in at least one dimension and with longest diameter ≥20 mm using
conventional techniques or ≥10 mm with CT spiral scan.

5. Patients with progressive disease in the previous 6 months before their inclusion in the study. Is is needed to demonstrate the appearance of one or more new lesions or an increase ≥20% of the sum of the longest diameters of "target lesions" (2) or an unequivocal progression of "not target lesions" (3).
(2) "target lesions": all measurable lesions up to a maximum of 5 per organ and
10 lesions in total. Size (lesions with the longest diameter) and their
suitability for accurate repeated measurements will be taken into account for
their selection.
(3) "not target lesions": all lesions, or disease locations (e.g. ascites, pleural
effusion), not regarded as "target lesions".

6. Patients with 0-2 punctuation in the ECOG Scale (Eastern Cooperative Oncological Group) for general condition assessment.
0 Fully active, able to carry on all pre-disease performance without restriction.
1 Restricted in physically strenuous activity but ambulatory and able to carry
out work of light or sedentary nature, e.g., light house work, office work.
2 Ambulatory and capable of all selfcare but unable to carry out any work
activities. Up and about more than 50% of awaking hours.
3 Capable of only limited selfcare, confined to bed or chair more than 50% of
awaking hours.
4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or
chair.

7. Patients with positive (111-In-DTPA-D-Phe) octreotide scintigraphy.



E.4Principal exclusion criteria
1. Patients with surgical removable localised disease.

2. Patients with progressive disease in the first six months of being diagnosed.

3. Patients with carcinoid tumours which cause intestinal obstruction.

4. Patients with life expectancy under 12 weeks.

5. Patients who have received treatment with somatostatine analogues during the 6 months before being included in the study.

6. Patients who have received treatment with radiotherapy, chemotherapy or interferon 4 weeks before being included in the study, or planned during the study.

7. 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.

8. Breast-feeding or pregnant women (Beta-HCG will be measured before the patients are included) or high risk of getting pregnant due to inadequate contraceptive measures.

9. Patients with physical comorbidity or mental or social alteration that prevent them to understand and carry out the treatment.
E.5 End points
E.5.1Primary end point(s)
Time until disease progression, that is, according to RECIST criteria (Response Evaluation Criteria in Solid Tumors), appearance of one or more new lesions or an increase ≥20% of the sum of the longest diameters of "target lesions" taking as reference the baseline sum of longest diameters recorded at the beginning of the study, or an unequivocal progression of "not target lesions".
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee Information not present in EudraCT
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
Last visit of the last patient recruited in the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months3
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state30
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-02-09
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-01-13
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2009-11-02