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    Summary
    EudraCT Number:2008-007348-32
    Sponsor's Protocol Code Number:SOM230D2203
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-30
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2008-007348-32
    A.3Full title of the trial
    An open label, multicenter, single arm study of pasireotide LAR in patients with rare tumors of neuroendocrine origin
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberSOM230D2203
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice / MCC
    B.5.3 Address:
    B.5.3.1Street AddressRoonstraße 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+491802232300
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@novartis.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEC/3/04/200
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEC/3/04/200
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEC/3/04/200
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    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 INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    The following tumors are included:
    1. NETs of the pancreas or duodenum: Insulinoma, Gastrinoma, VIPoma, glucagonoma,
    2. Pituitary NETs: Thyrotropic-pituitary adenoma (TSH), Gonadotropic adenoma, Prolactinoma (PRL) and non-functioning pituitary adenoma (NFPA)
    3. Ectopic ACTH-secreting (EAS) tumors
    4. Nelson's syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10062476
    E.1.2Term Neuroendocrine tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of pasireotide LAR in pancreatic and duodenum NETs (Insulinoma, Gastrinoma, VIPoma, and Glucagonoma) based on disease specific primary biochemical tumor markers.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of pasireotide LAR in each of the pancreatic and duodenum NETs (Insulinoma, Gastrinoma, VIPoma and Glucagonoma) based on disease specific primary biochemical tumor markers
    - To assess the efficacy of pasireotide LAR in each of the other rare NETs including Prolactinoma, Thyrotropic adenoma, Gonadotropic adenoma, Non functioning pituitary adenoma, Ectopic ACTH-secreting tumors and Nelsons syndrome based on disease specific primary biochemical tumor markers.
    - To evaluate the overall safety and tolerability of pasireotide LAR
    - To evaluate the effect of pasireotide LAR on disease-related symptoms.
    - To evaluate the pharmacokinetics (PK) trough plasma concentrations of pasireotide LAR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ?18 years.
    2. Patients who have failed standard of care treatment or for whom no standard of care treatment is available.
    3. Patients with rare neuroendocrine tumors of pancreas or duodenum must meet each of the following:
    � Pathologic confirmation: Patients must have histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, or goblet cell carcinoid are not eligible. If the pathology report states only neuroendocrine carcinoma, then the pathology subtype must be reconfirmed.
    � Advanced metastatic or unresectable disease
    � Patients must have biochemical evidence of hormone production and clinical symptoms consistent with diagnosis Insulinoma, Gastrinoma, VIPoma or Glucagonoma. Biochemical evidence can include values of a historical nature: (1) values used to establish the original diagnosis and/or (2) most recently available abnormal value(s).
    4. Patients with rare neuroendocrine tumors of pituitary must meet each of the following:
    � MRI documenting the presence of a pituitary tumor
    � Patients must have biochemical evidence of hormone production (and clinical symptoms consistent with diagnosis of TSH-secreting, gonadotropic secreting, prolacting secreting or non-functioning pituitary adenoma. Biochemical evidence can include values of a historical nature: (1) values used to establish the original diagnosis and/or (2) most recently available abnormal value(s).
    5. Patient with EAS tumors and Nelson�s syndrome should have confirmed diagnosis by the investigator with criteria consistent with [Post Text Supplement 1]. Biochemical evidence can include values of a historical nature: (1) values used to establish the original diagnosis and/or (2) most recently available abnormal value(s).
    6. ECOG performance status ? 2.
    7. Patients must observe the following intervals between the last injection of their previous treatment and the first injection of study drug:
    � Octreotide LAR = 28 days (4 weeks)
    � Octreotide s.c. = 8 hours
    � Lanreotide Autogel = 28 days (4 weeks)
    � Lanreotide SR = 14 days (2 weeks)
    8. Written informed consent obtained prior to any screening procedures.
    E.4Principal exclusion criteria
    1. Patients with active gallbladder disease.
    2. Patients with any ongoing or planned anti-neoplastic therapy.
    3. Patients with any ongoing or planned therapy with interferon.
    4. Poorly controlled diabetes mellitus as indicated by the presence of HbA1c > 8% (Not applicable for glucagonoma patients).
    5. Patients with radiolabelled somatostatin analogue therapy within 6 months of visit 1, cytotoxic therapy or interferon within 2 months of visit 1 or radiotherapy within 1 month of visit 1.
    6. Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator or the Sponsor�s Medical Monitor.
    7. Any of the following cardiac abnormalities:
    � QTcF at screening > 450 msec
    � History of syncope or family history of idiopathic sudden death
    � Sustained or clinically significant cardiac arrhythmias
    � Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
    � Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
    � Concomitant medication(s) known to increase the QT interval
    8. Any of the following hepatic related exclusion criteria:
    • History of liver disease, such as cirrhosis or chronic active hepatitis B and C
    • Presence of Hepatitis B surface antigen (HbsAg)
    • Presence of Hepatitis C antibody (anti-HCV)
    • History of, or current alcohol misuse/abuse within the past 12 months
    • Known gallbladder or bile duct disease, acute or chronic pancreatitis
    • Baseline ALT or AST > 3 x ULN
    • Baseline total bilirubin > 1.5x ULN
    9. Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits)
    10. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control.
    � Female patients of child-bearing potential must use barrier contraception with condoms. The use of intra uterine device for all women and oral contraception for all women is allowed except for those patients diagnosed with non-functioning pituitary adenoma and gonadotroph adenoma.
    � If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended.
    � Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs). Female partners of these male patients must use a secondary barrier contraception.
    11. Patients who have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.
    12. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study.
    E.5 End points
    E.5.1Primary end point(s)
    - Patient response criteria: Patient response will be assessed for each tumor type by the change in the primary biochemical tumor marker value from baseline after 6 months of pasireotide LAR treatment. A patient will be considered a responder if there is a >50% decrease or normalization in the level of the primary biochemical tumor marker from baseline after 6 months of pasireotide LAR treatment. Biochemical tumor markers (including primary and non-primary markers) are presented for each specific disease in [Post Text Supplement 1]. In general, these rare tumors are not well characterized and while normalization of the primary biochemical tumor marker is the optimal goal, a 50% decrease in a biochemical tumor marker is anticipated to correlate with improvement in clinical signs/symptoms.

    - Primary Efficacy: The proportion of responders among the patients with pancreatic and duodenum NETs (Insulinoma, Gastrinoma, VIPoma, and Glucagonoma).

    - Secondary Efficacy:
    1. The proportion of responders in each type of pancreatic and duodenum NETs including Insulinoma, Gastrinoma, VIPoma and Glucagonoma.
    2. The proportion of responders in each of the other rare NETs including Prolactinoma, Thyrotropic adenoma, Gonadotropic adenoma, Non functioning pituitary adenoma, Ectopic ACTH-secreting tumors and Nelsons syndrome
    3. The associated disease related symptoms present at baseline will be followed throughout the study using Memorial Symptom Assessment Scale (MSAS).

    - Exploratory Efficacy: The primary biochemical tumor markers will be summarized longitudinally, i.e. % change from baseline by visit.

    - Safety: Overall safety and tolerability of pasireotide LAR will be assessed by changes in vital signs and laboratory values including ECGs, urinalyses and blood chemistries. Additionally, patients will be monitored for the occurrence of adverse events at each study visit.

    - PK: The PK of pasireotide LAR will be assessed by measurements of trough plasma concentrations.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single arm study
    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.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    Mexico
    Russian Federation
    South Africa
    United States
    E.8.7Trial has a data monitoring committee No
    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
    After 6 months treatment, patients who don't demonstrate clinical benefit will be discontinued, those who don't meet prespecified criteria but benefit from treatment and those who demonstrate clinical benefit may continue in the extension study.Extension:up to 4 years or until lack of clinical benefit as assessed by the investigator, unacceptable AEs, withdrawal of consent or until pasireotide LAR or other effective therapy becomes commercially available (whichever comes first).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 120
    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 Decision2009-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-10
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