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    Summary
    EudraCT Number:2012-001098-94
    Sponsor's Protocol Code Number:D12-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-27
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2012-001098-94
    A.3Full title of the trial
    A randomized phase II double-blind trial of sunitinib versus placebo in combination with lanreotide in patients with progressive advanced/metastatic midgut carcinoid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of sunitinib versus placebo in combination with lanreotide in patients with progressive advanced/metastatic intestinal endocrine tumor.
    A.3.2Name or abbreviated title of the trial where available
    SUNLAND
    A.4.1Sponsor's protocol code numberD12-01
    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 SponsorGERCOR
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportIPSEN
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportGERCOR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGERCOR
    B.5.2Functional name of contact pointHADENGUE
    B.5.3 Address:
    B.5.3.1Street Address151 rue du Faubourg St Antoine
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75011
    B.5.3.4CountryFrance
    B.5.4Telephone number33140298500
    B.5.5Fax number33140298508
    B.5.6E-mailgercor@gercor.com.fr
    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 Yes
    D.2.1.1.1Trade name Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER Limited UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSunitinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 341031-54-7
    D.3.9.3Other descriptive nameSUNITINIB MALATE
    D.3.9.4EV Substance CodeSUB22366
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 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 Yes
    D.2.1.1.1Trade name Somatuline L.P
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameLanreotide
    D.3.4Pharmaceutical form Prolonged-release suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 108736-35-2
    D.3.9.4EV Substance CodeSUB08402MIG
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progressive advanced/metastatic midgut carcinoid tumors
    E.1.1.1Medical condition in easily understood language
    Progressive advanced/metastatic intestinal endocrine tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10068118
    E.1.2Term Metastatic carcinoid 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 evaluate the efficacy of the combination of sunitinib with lanreotide and of placebo with lanreotide regarding progression-free-survival (PFS) as assessed by local investigators
    E.2.2Secondary objectives of the trial
    To evaluate overall survival (OS) in sunitinib- and placebo-treated subjects.
    - To evaluate duration of response (DR) in sunitinib- and placebo-treated subjects in subjects achieving a response.
    - To evaluate objective response (OR) rate in sunitinib- and placebo-treated subjects.
    - To assess time to tumor response (TTR) for sunitinib- and placebo-treated subjects.
    - To assess Health related Quality of life (EORTC QLQ C-30).
    - To evaluate the symptomatic effects of sunitinib in subject with carcinoid syndrom.
    - To evaluate the best biological responses as assessed using serum chromogranin A and urine 5HIAA for sunitinib- and placebo-treated subjects.
    - To evaluate plasma levels of VEGF-A, VEGF-C, sKIT, and sVEGFR2 as determined by Elisa assay for sunitinib- and placebo-treated subjects, at baseline, 1-month treatment, at first tumor evaluation and at the end of study treatment (optional).
    - To assess safety and tolerability of sunitinib in the study population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Patients with midgut well-differentiated Grade 1-2 endocrine tumor (ENETS guidelines). Pathological confirmation might have been obtained from primary tumor (surgical resection), or lymph node/liver metastases. Histologically documented endocrine liver metastases with unknown primary are eligible if the patient has history of carcinoid syndrome with elevated serum chromogranin A and urinary 5HIAA levels.
    * Local, locally advanced or metastatic disease documented as progressive by RECIST v1.1. on CT-scan or MRI at baseline and within 12 months prior to baseline. The previous scans will be used to classify the patient as having progressive disease at baseline according to RECIST v1.1 criteria. Octreoscan results may be used to document progressive disease at baseline, but not for RECIST v1.1 determination during the study.
    Locally advanced liver metastasis, corresponding to >50% liver involvement as documented on baseline CT-scan or MRI by the local investigator, are eligible regardless prior progression
    * Chromogranin A and 5HIAA levels >1.5ULN as measured in each individual centre
    * Disease that is not amenable to surgery with curative intent
    * ECOG Performance status 0 or 1
    * Age more than 18 years
    * Able to swallow oral compound
    E.4Principal exclusion criteria
    * Patients with undifferentiated, poorly differentiated gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, bronchial carcinoid tumors (WHO 2010 classification)
    * Patients with carcinoid tumors with the presence of an obstructive intestinal tumor
    * Patients with uncontrolled cardiac complication as part of their carcinoid syndrome
    * Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational anticancer agent other than somatostatin analogues
    * Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors (such as bevacizumab, sorafenib, or sunitinib). Prior treatment with non-VEGF-targeted angiogenic inhibitors such as everolimus or temsirolimus is permitted
    * Patients who stopped everolimus treatment was less than 4 weeks prior to randomization
    * Patients with concomitant treatment with interferon
    * Concomitant treatment with a drug having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide)
    * Unstable systemic diseases including uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy) or active uncontrolled infections
    * Ongoing cardiac dysrhythmias of NCI CTC grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free-Survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from date of randomization to first progression of disease (PD) or death for any reason in the absence of documented PD
    E.5.2Secondary end point(s)
    - Overall survival is defined as the time from date of randomization to date of death. In the absence of confirmation of death, survival time will be censored to last date the subject is known to be alive.
    - The objective response (OR) is the overall objective response recorded from randomization until disease progression: sustained complete response (CR) or partial response (PR) according to RECIST v1.1 definitions for at least 4 weeks, confirmed by tumor assessments.
    - Duration of response (DR) is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival :time from date of randomization to date of death. In the absence of confirmation of death, survival time will be censored to last date the subject is known to be alive.
    Overall objective response: recorded from randomization until disease progression
    Duration of response:time from the first documentation of objective tumor response
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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 subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 73
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment of that condition
    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 Decision2012-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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