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    Summary
    EudraCT Number:2010-019017-25
    Sponsor's Protocol Code Number:CSOM230CIC01T
    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:2010-11-08
    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 number2010-019017-25
    A.3Full title of the trial
    Efficacy of medical treatment with SOM230 LAR in patients with primary inoperable thymoma and/or with local recurrent thymoma to reduce tumor size
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Die Wirksamkeit einer medikamentösen Behandlung mit SOM230 LAR hinsichtlich Tumorgrößenreduktion bei Patienten mit primär inoperablem Thymom und/oder einem lokalen Thymomrezidiv
    A.4.1Sponsor's protocol code numberCSOM230CIC01T
    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 SponsorFreistaat Bayern, represented by Universität Regensburg
    B.1.3.4CountryGermany
    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 supportUniversität Regensburg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROLLL GmbH
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressWörnitzstraße 115a
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90449
    B.5.3.4CountryGermany
    B.5.4Telephone number4991125268848
    B.5.5Fax number4991125268840
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePasireotide LAR
    D.3.2Product code SOM230 LAR
    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 LAR
    D.3.9.2Current sponsor codeSOM230 LAR
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePasireotide LAR
    D.3.2Product code SOM230 LAR
    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 LAR
    D.3.9.2Current sponsor codeSOM230 LAR
    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.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
    Primary inoperable thymoma and/or local recurrent thymoma
    E.1.1.1Medical condition in easily understood language
    primär inoperabler Thymom und/oder einem lokalen Thymomrezidiv
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10043670
    E.1.2Term Thymoma
    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
    • Tumor shrinkage
    Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline.
    E.2.2Secondary objectives of the trial
    • Resection status
    The frequency distribution of the resection status will be presented based on the categories R0, R1 and  R2
    • Evaluation of histological and flow cytometric changes under treatment with SOM230 LAR.
    1) percentage of necrotic area
    2) degree of depletion (none, slight; moderate; marked) of immature T-cells (immunohistochemistry for CD1a, CD99, CD3 expression
    3) change of T-cell subset composition as revealed by FACS analysis (Ströbel et al. BLOOD, 2002).
    • Safety
    The assessment of safety will be based mainly on the frequency of Adverse Events and on the number of laboratory values that fall outside of pre-determined ranges.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged ≥18 years
    2. Diagnosis of thymoma as assessed by biopsy and/or szintigraphy
    3. Inoperability of thymoma or loco-regional metastases. Inoperability is defined as at least adherence of the tumor to the neighbored organs, suspicious to infiltrate neighbored organs or local metastasis so that R0 resection can not be expected and /or local recurrence of thymic tumor
    4. Tumor stage: Thymomas of all WHO based histological subtypes (WHO A, AB, B1, B2, B3) (Rosai, 1999; Travis 2004) at Masaoka stage II to IVa based on histological examination of resection specimens or core biopsies.
    5. Patients with and without thymoma associated paraneoplastic syndrome.
    6. Performance status 0,1, or 2 (ECOG)
    7. Patients for whom written informed consent to participate in the study has been obtained
    E.4Principal exclusion criteria
    • Patients having received radiolabeled somatostatin analogue therapy within the 6 months or any cytotoxic chemotherapy or interferon therapy within the 2 months prior to recording baseline symptoms
    • Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months before recording baseline symptoms
    • Patients who have received radiotherapy for any reason within the last 4 weeks and must have recovered from any side effects of radiotherapy before recording baseline symptoms
    • Patients who are not biochemically euthyroid
    • Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as indicated by HbA1C > 8%
    • Patients with symptomatic cholelithiasis
    • Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
    • Patients with QT related risk factors:
    - QTcF at screening > 450 msec
    - History of syncope or family history of idiopathic sudden death
    - Sudden 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
    • Patients with potassium <3.0 mmol/L at study entry, magnesium <0.4 mmol/L at study entry, calcium <1.75 mmol/L at study entry, family history of long QT syndrome, and concomitant medications known to prolong the QT interval. If the electrolyte abnormalities are corrected prior to study commencement, the patient may become eligible for the trial.
    • Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, serum albumin < 0.67 X LLN, and/or ALT or AST more than 2 X ULN for patients without liver metastases or ALT or AST more than 5X ULN for patients with documented liver metastases
    • Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
    • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
    • Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits)
    • Patients with WBC <2.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L (patients with paraneoplastic pan-, leuco-, erythro- or thrombopenia can be included if this seems to be the only reason for pan-, leuco-, erythro- or thrombopenia)
    • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations
    • 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
    • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use a secure method of contraception if sexually active and the partner should use a condom. If oral contraception is used , 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 should use a secondary barrier contraception.
    • Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
    • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
    • Patient has received any other investigational agents within 28 days of first day of study drug dosing
    • Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results
    E.5 End points
    E.5.1Primary end point(s)
    Tumor shrinkage
    Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    EOS
    E.5.2Secondary end point(s)
    Resection status
    The frequency distribution of the resection status will be presented based on the
    categories R0, R1 and >= R2.

    Evaluation of histological and flow cytometric changes under treatment with
    SOM230 LAR.
    1) percentage of necrotic area
    2) degree of depletion (none, slight; moderate; marked) of immature T-cells
    (immunohistochemistry for CD1a, CD99, CD3 expression
    3) change of T-cell subset composition as revealed by FACS analysis (Ströbel et
    al. BLOOD, 2002).

    E.5.2.1Timepoint(s) of evaluation of this end point
    EOS
    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 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 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) 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 Information not present in EudraCT
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    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.1.2.1Number of subjects for this age range: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state16
    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 Decision2011-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-30
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