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    Summary
    EudraCT Number:2006-004076-13
    Sponsor's Protocol Code Number:5
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2006-10-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-004076-13
    A.3Full title of the trial
    Secar I
    Part I: A study of MTD of Sodium selenite in patients with advanced carcinoma. A phase I study.
    Amendment 5: continuous treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SECAR I.
    Part I: Sodium selenite as a treatment against cancer. Search for the highest possible dose given as continuous infusion.
    Amendment 5.
    A.3.2Name or abbreviated title of the trial where available
    The Secar study
    A.4.1Sponsor's protocol code number5
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01959438
    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 SponsorHuvud- hals- lung- och hudcancer, Tema Cancer Karolinska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 supportStockholms Läns Landsting (ALF-tid)
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportCancerfonden
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportCancer och allergifonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHuvud- hals- lung- och hudcancer, Tema Cancer Karolinska University Hospital
    B.5.2Functional name of contact pointClara Lenneby-Helleday
    B.5.3 Address:
    B.5.3.1Street AddressRadiumhemmet, Karolinska Universitetssjukhuset
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)85177000
    B.5.6E-mailclara.helleday@sll.se
    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 Intro-Selen iv
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Nord ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameIntro-Selen iv
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIntroselen iv
    D.3.9.3Other descriptive nameSodium selenite
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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
    Patients with stage III or IV cancer in whom first and second line treatment have been given but who have tumours that are still progressing, giving symptomes. The patients must be in a fairly good condition (performance status 0-2) and considered to manage the treatment, sodiumselenite and chemotherapy as out-patients.
    The study treatment might be considered as a last rescue in this group of patients with an expected median survival of only a few months.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced cancer which is progressing in spite of treatment with established drugs. The patients must be in fairly good general condition to manage the planned treatment.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial has two parts. In the first, phase I part, the objective is to find the MTD of sodiumselenite. The patients will receive a 2 (or 3) day continuous infusion of sodium-selenite and after that a response evaluation will be performed. If not progression, the patient will receive 2 more 2 day infusions. A new response evaluation is now performed. After that (or immediately if progression) the patient will be treated with 3-4 courses with the kind of chemotherapy that has been used as first line treatment. Then the last response evaluation is done.
    In the second, the phase II part, the objective is to find out if sodium-selenite given at MTD dose has an anti-tumor effect, either alone or after the chemotherapy treatment.
    Both in the phase I and phase II studies we will aim to get tumor samples before and immediately after the selenite treatment.
    Thus the primary endpoint in the phase I study is MTD and safety and in the phase II responses.
    E.2.2Secondary objectives of the trial
    In the phase I study:Responses, degree and duration. Survival. Dose/toxicity correlation
    In the phase II study: Toxicity, type, degree, duration, safety. Dose /effect correlation
    In both parts of the study:
    Pharmacokinetics of sodium-selenite. Metabolism of selenite, expression of selenoproteins.
    Search for predictive markers
    Relation, if any, between the level of thioredoxinreductase and antitumoural effect
    Impact of selenite on interleukines and other immunological factors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Advanced malignant disease of any kind.
    2. Histologically or cytologically verified tumor.
    3. Progressing tumor in spite of earlier treatment with established drug treatment for respective tumor. (It is the patient´s responsible doctor, who decides that).
    4. All stages, but according to point 3, mostly stage IV patients will be considered for inclusion. Patients with brain metastases might be considered if they have been treated with irradiation or surgery and are free from symptoms of the brain metastase.
    5. Performance status 0, 1 and 2.
    6. More than 18 years of age.
    7. Radiation therapy or chemotherapy should not have been given for at least 3 weeks before start of selenite.
    8. The patient must accept to give blood and urine samples for routine and researhc purposes. It is desirable to take tumor biopsies twice (before and after selenite treatment). If biopsy taking is associated with a high risk for serious complications, this will not be done.
    9. Spoken and written informed consent.
    10. The patient must accept that data are checked by a person outsied the study (monitor).
    11. The patient and the PAL (patient responsible doctor) must accept that the study treatment and the follow-ups within the study are performed at the HHH section of Radiumhemmet, Karolinska University Hospital. A note to the patient´s record should be performed by the PAL that 1) established drug treatment has been given and 2) that the 12 week´s treatment within the SECAR study shall be undertaken at the HHH section of Radiumhemmet.

    E.4Principal exclusion criteria
    1. Dysfunction of heart, kidney (cystatin C >1.60, if on limit Pt-eGFR <50), liver (bilirubin >50) or other organs that might give a considerable increased risk for patient safety.
    2. Impaired ability to cooperate.
    3. The tumour not possible to evaluate.
    4. Two or more concurrent malignancies. If no signs of one of them during the last 3 years, the patient can be included.
    5. Ongoing treatment with antidepressive drugs.
    6. Obstacle in the pharynx giving risk for aspiration pneumonia if vomiting.
    7.Brain metastases giving symptoms and also symptomless brain metastases localised in the pons region. CT-scan of the brain, not older that 6 weeks before start of treatment must be free from metastases in the pons region. Patients with treated brain metastases (irradiation or surgery) and free from symptoms can be included.
    8. Patients with HIV/AIDA or hepatitis B/C with respect to increased risks for nurses and laboratory people working with blood samples.
    E.5 End points
    E.5.1Primary end point(s)
    In the first, phase I part: Primary endpoint: MTD (safety). The patients will receive 2 and 3 days, respectively continuous infusion with sodiumselenite. A PET-CT scan will be performed just before and after the first treatment. If no tumor progression 2 more continuous infusions will be given. A CT scan if taken . After that (or if progression after the first infusion) chemotherapy, 3 -4 courses will be given and a CT scan taken. After that an End of treatment meeting with the doctor (investigator) ends the participation of the patient and after that the patient goes back to the ordinary doctor. No late selenite toxicity has been observed so far.
    Cohorts of 3 patients will receive the same dose starting with 14.3 mg/m2. If 0/3 patients gets dose limiting toxicity (DLT) the study goes on to the next higher dose (50% higher) If 1/3 patients gets DLT, 3 more patients are included on that dose. If 2/6 patients get DLT this dose level is considered too high and the next lower is considered the MTD.
    In the phase II study responses are obtained as soon as the end of treatment control of the last patient is performed.
    Initially 15 patients will be included. For each patient responding (SD, PR or CR) 3 more patients will be included up to 45 patients.
    Thus toxicity and safety will be known when the last patient has had his or her last visit within the study. Survival will be followed in patient records. If treatment with sodium selenite results in complete remission in most patients (80 %), without unacceptable toxicity, the phase I study might be stopped before MTD. In that case we will contact Läkemedelsverket for further discussions.

    In the second, phase II part:
    Objective tumor responses; frequency, degree and duration. Responses will be followed by PET-CT scans and CAT scans as described in the phase I study above. Besides routine blood samples on liver, kidney thyreoid and bone marrow function will be taken. Also tumor markers will be followed.
    Besides, tumor biopsies will be taken just before and after the selenite treatment and we will check these with respect to apoptosis and necrosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the phase I study, MTD will be obtained when the end of treatment control of the last patient is performed.
    In the phase II study, responses will be checked up during the study. They will also be checked extra by a reference radiologist later on. But principally, the result will be known when the last patient has come for the end of treatment consultation.
    E.5.2Secondary end point(s)
    This will take longer, and analysis will be performed during half a year after the stop of inclusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These results will take longer, since measurement of selenite is performed a few times during each study and the same is true about speciation of selenite metabolites. Calculation of pharmacokinetics will be performed when all data on selenium in plasma have arrived. Similarily it will take extra time to obtain data on necrosis and apoptosis of selenium biopsies and chemosensitivity of ex vivo studies of chemosensitivity. These data, however, have no impact on the duration of inclusion time , only on time to publication.
    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 No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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.8.3 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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    None
    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 Decision2006-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-21
    P. End of Trial
    P.End of Trial StatusRestarted
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