Страница клинических исследований Nct

Summary
EudraCT Number:2004-001091-40
Sponsor's Protocol Code Number:2-47-52030-722
National Competent Authority:Finland - Fimea
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2004-08-06
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedFinland - Fimea
A.2EudraCT number2004-001091-40
A.3Full title of the trial
A Phase III, Prospective, Multicentre, Randomised, Open, Parallel Group Comparison of Lanreotide Autogel (90 and 120mg) Administered by Deep Subcutaneous Injection Every Four Weeks, with Sandostatin LAR Depot (20 and 30mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated with Carcinoid Syndrome.
A.4.1Sponsor's protocol code number2-47-52030-722
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 SponsorBeaufour Ipsen Pharma
B.1.3.4CountryFrance
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 Somatuline Autogel 90mg
D.2.1.1.2Name of the Marketing Authorisation holderIpsen Scandinavia, Park Alle 292, 2695 Brondby, Tanska
D.2.1.2Country which granted the Marketing AuthorisationFinland
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.3.1Product nameSomatuline Autogel
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 acetate
D.3.9.1CAS number 127984-74-1
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number90
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.IMP: 2
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 Somatuline Autogel 120mg
D.2.1.1.2Name of the Marketing Authorisation holderIpsen Scandanvia, Park Alle 292, 2605 Brondby, Tanska
D.2.1.2Country which granted the Marketing AuthorisationFinland
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.3.1Product nameSomatuline Autogel
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 acetate
D.3.9.1CAS number 127984-74-1
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.IMP: 3
D.1.2 and D.1.3IMP RoleComparator
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 Sandostatin LAR 20mg
D.2.1.1.2Name of the Marketing Authorisation holderNovartis Finland Oy, Metsanneidonkuja 10, 02130, ESPOO
D.2.1.2Country which granted the Marketing AuthorisationFinland
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.3.1Product nameSandostatin LAR
D.3.4Pharmaceutical form Suspension for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNOctreotide acetate
D.3.9.1CAS number 79517-01-4
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
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.IMP: 4
D.1.2 and D.1.3IMP RoleComparator
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 Sandostatin LAR 30mg
D.2.1.1.2Name of the Marketing Authorisation holderNovartis Finland Oy, Metsanneidonkuja 10, 02130 ESPOO
D.2.1.2Country which granted the Marketing AuthorisationFinland
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.3.1Product nameSandostatin LAR
D.3.4Pharmaceutical form Suspension for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNOctreotide acetate
D.3.9.1CAS number 79517-01-4
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number30
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
Treatment of clinical symptoms of carcinoid syndrome.
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 the efficacy of lanreotide Autogel (90 and 120 mg), compared with
Sandostatin LAR Depot (20 and 30 mg), in terms of the frequency of target
symptom episodes, assessed by the change from baseline in the average daily
number of episodes of the target symptom at Week 24.
E.2.2Secondary objectives of the trial
To evaluate the efficacy of lanreotide Autogel (90 and 120 mg), compared with
Sandostatin LAR Depot (20 and 30 mg), with regard to:
• Change from baseline in daily stool frequency at Week 24.
• Change from baseline in daily flushing frequency at Week 24.
• Change from baseline in urinary 5-HIAA at Week 24.
• Change from baseline in plasma chromogranin A at Week 24.
• Use of Sandostatin Injection as rescue medication.
• Use of anti-diarrhoeal medication.
Other secondary efficacy analyses may include change from baseline in target
symptom, daily stool episodes, and daily flushing episodes at Week 4, 8, 12, 16 and
20.
To evaluate the safety of lanreotide Autogel (90 and 120 mg) and Sandostatin LAR
Depot (20 and 30 mg) over six months, with regard to the following assessments:
• Treatment-emergent AEs.
• Gallbladder ultrasound (sludge or lithiasis).
• Echocardiography.
• Local tolerance.
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
At the screening visit patients MUST satisfy all of the following criteria before they
will be allowed to participate in the study:
a) Male or female of 18 years of age or older.
b) Histologically confirmed diagnosis of a neuroendocrine tumour of the carcinoid
type
c) Documented evidence of carcinoid syndrome (flushing and/or diarrhoea)
attributable to a primary tumour of the lung, stomach or mid-gut
d) Previous positive Octreoscan.
e) World Health Organisation (WHO) performance score lower than 2 (Appendix 2 of protocol).
f) Written informed consent given.
At the baseline visit patients MUST satisfy the following criteria before they are randomised to receive study treatment:
g) Stool and/or flushing frequency of ≥3 episodes/day (average over a minimum
five consecutive days).
h) Patients who have previously been treated with somatostatin analogues must
have discontinued treatment for a sufficient period of time (a washout period of
at least 7 days for immediate release formulations and up to 2 months for
prolonged release formulations is usually required). Compared with their
"controlled" state on treatment, these patients must show a clinically significant
deterioration (at least two episodes) of either symptom. For example, a patient
considered to be controlled on their previous treatment with an estimated stool
frequency of two episodes per day, must achieve a stool frequency of at least
four episodes per day (average over a minimum five consecutive days).
i) WHO performance score lower than 2 (Appendix 2 of protocol).
E.4Principal exclusion criteria
If any of the following criteria apply the patient must not enter/continue in the study:
a) VIPoma or other non-carcinoid tumour.
b) Treatment with interferon, chemotherapy or radiotherapy given within 30 days
prior to inclusion, or planned during the study.
c) Radionuclide treatment within three months prior to inclusion, or planned during
the study.
d) Presence of other active malignant pathology (except basal cellular carcinoma of
the skin and/or in situ carcinoma of the cervix/uterus).
e) Surgical procedure or embolisation procedure (with or without cytotoxic agents)
of the tumour within three months prior to inclusion, or planned during the
study.
f) Patient is pregnant, lactating, or not taking adequate precautions against
pregnancy. (NB Patients of childbearing potential must demonstrate a negative
serum pregnancy test, and be using appropriate double methods of contraception, such as approved hormonal contraceptives or a condom used with a spermicide).
g) Life expectancy of less than 6 months.
h) Known hypersensitivity to any of the test materials or related compounds.
i) Any investigational drug given within 30 days prior to inclusion or expected to be given during the study.
j) Previous participation in this study.
k) No access to a telephone for completion of the daily telephone diary.
l) In the opinion of the investigator the patient is unable and/or unwilling to
comply fully with the protocol and the study instructions.
E.5 End points
E.5.1Primary end point(s)
Target symptom frequency.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence Yes
E.6.9Dose response Yes
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.3.1Comparator description
Sandostatin injection 200micrograms (1mg/5mg); Sandostatin LAR 20mg; Sandostatin LAR 30mg
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 Yes
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
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
End of trial is defined as last patient attending study completion (week 24) visit.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
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 state6
F.4.2 For a multinational trial
F.4.2.1In the EEA 98
F.4.2.2In the whole clinical trial 196
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 Decision2004-09-22
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-09-03
P. End of Trial
P.End of Trial StatusCompleted

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