Phase III, randomised, double-blind, stratified comparative, placebo controlled, parallel group, multicentre study to assess the effect of deep subcutaneous injections of lanreotide Autogel 120 mg administered every 28 days on tumour progression free survival in patients with non functioning entero-pancreatic endocrine tumour.
- Conditions
- Endocrine TumoursTumours originating from cells which secrete hormones.10014713
- Registration Number
- NL-OMON30553
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
- Has provided written informed consent prior to any study related procedures,
- Is a male or a female of 18 years of age or older,
- Has an endocrine tumour confirmed by centrally assessed histological
criteria.
-Has metastatic disease and/or locally advanced inoperable tumour, or the patient has refused surgery (documented)
-Has a tumour measurable according to RECIST criteria (central assessment),
-Has no hormone related symptoms,
-Has a non-functioning entero-pancreatic endocrine tumour of unknown origin: or with a known primary localisation in pancreas, mid-gut or hind gut, or a gastrinoma adequately controlled by proton-pump inhibitors (4 month stable prior to study entry).
- Has a well or moderately differentiated tumour (central assessment),
-Has a tumour with proliferation index (Ki67) < 10% or, in samples where the Ki67 antigen cannot be reliably quantified, a mitotic index less or equal to 2 mitosis/10HPF. (central assessment)
-Has a >= grade 2 octreoscan assessed using the Krenning scale, during the
screening period or within 6 months prior to study entry (Visit 1) for the organ
of target lesions (Appendix 1),
-Has a World Health Organisation (WHO) performance score lower or equal to 2
- Has been treated with a somatostatin analogue at any time prior to study entry
(Visit 1), except if that treatment was for less than 15 days (e.g. peri-operatively)
and the treatment was received more than 6 months before study entry (Visit 1),
- Has been treated with radionuclide at any time prior to study entry (Visit 1),
- Has been treated with interferon, chemoembolisation or chemotherapy within 6
months prior to study entry (Visit 1),
- Has had a previous cancer (except basocellular carcinoma of the skin and/or in
situ carcinoma of the cervix/uterus and/or patients treated with curative intend
and free from disease for more than 5 years),
- Has a history of hypersensitivity to drugs with a similar chemical structure,
- Has been treated with any other unlicensed drug within the last 30 days before
study entry (Visit 1),
- Is likely to require treatment during the study with drugs that are not permitted
by the study protocol (see Section 9.6),
- Is at risk of pregnancy or is lactating. Females of childbearing potential must
provide a negative pregnancy test at study entry (Visit 1) and must be using oral,
double barrier or injectable contraception. Non childbearing potential is defined
as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at
least three months before the start of the study,
- Has any mental condition rendering the patient unable to understand the nature,
scope and possible consequences of the study, and/or evidence of an
uncooperative attitude,
- Has abnormal baseline findings, any other medical condition(s) or laboratory
findings that, in the opinion of the investigator, might jeopardise the patient*s
safety or decrease the chance of obtaining satisfactory data needed to achieve
the objective(s) of the study,
- Has been previously enrolled in this study,
- Has had major surgery related to the studied disease within 3 months prior to entering the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be time to either disease progression (measured using<br /><br>RECIST criteria) or death, occuring within 96 weeks after first study treatment<br /><br>administration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Proportion of patients without tumour progression or death in each treatment<br /><br>group at 48 and 96 weeks.<br /><br>- Time to progression in each treatment group<br /><br>- Quality of life using EORTC QLQ-C30 and QLQ-GI-NET21 questionnaires at<br /><br>baseline and weeks 12,24,36,48,72 and 96.<br /><br>- Plasma chromogranin A level at baseline and weeks 12,24,36,48,60,72,84 and 96<br /><br>- Tumour markers (pancreatic polypeptide, gastrin, VIP, glucagon, somatostatin,<br /><br>insulin, neurotensin and urinary 5-HIAA) levels at baseline and weeks 48 and<br /><br>96. In addition, any tumour marker above normal range at baseline will be<br /><br>assessed at weeks 12,24,36,60, 72 and 84 and any tumour marker above normal<br /><br>range at week 48 will be assessed at weeks 60, 72 and 84.</p><br>