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

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2004-002871-18-ES
• Date of registration: 15/02/2006
• Prospective Registration: No
• Primary sponsor: IPSEN PHARMA, S.A.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 09/02/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002871-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Spain

Key inclusion & exclusion criteria

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.




Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with progressive neuroendocrine tumours who are not eligible to be treated with either surgery or chemotherapy

Intervention(s)

Trade Name: Somatulina Autogel® 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lanreotide
Current Sponsor code: 52030
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Secondary Objective:

Main Objective: 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.

Primary 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".

Secondary ID(s)

A-92-52030-166