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    Summary
    EudraCT Number:2006-005855-14
    Sponsor's Protocol Code Number:C2L-OCT-01 PR-301
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-20
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-005855-14
    A.3Full title of the trial
    OPEN LABEL, RANDOMIZED STUDY COMPARING THE BIOLOGICAL EFFICACY AND SAFETY OF A NEW PROLONGED RELEASE FORMULATION OF OCTREOTIDE ACETATE, C2L-OCT-01 PR, 30 MG ADMINISTERED INTRA MUSCULARLY EVERY 42 DAYS FOR 84 DAYS WITH SANDOSTATIN LAR® 30 MG ADMINISTERED INTRA MUSCULARLY EVERY 28 DAYS FOR 84 DAYS TO ACROMEGALIC PATIENTS
    A.4.1Sponsor's protocol code numberC2L-OCT-01 PR-301
    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 SponsorAmbrilia Biopharma Inc.
    B.1.3.4CountryCanada
    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 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 Sandostatin LAR
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis AG
    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 nameOCTREOTIDE ACETATE
    D.3.2Product code C2L-OCT-01 PR
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typesynthetic peptide
    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
    Acromegaly
    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 compare the mean serum concentrations of Insulin-Like Growth Factor-1 (IGF-1) and Growth Hormone (GH) in acromegalic patients treated with C2L-OCT-01 PR, 30 mg administered IM every 42 days for 84 days, or Sandostatin LAR® 30 mg administered IM every 28 days for 84 days
    E.2.2Secondary objectives of the trial
    - To compare the octreotide plasma concentrations in both groups.
    - To compare the clinical efficacy of both products based on changes in signs and symptoms of acromegaly, acromegaly severity index, patient’s health status.
    - To evaluate and compare the clinical and biological safety profile of both products
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion Criteria
    •Male or Female
    •Age ≥18 years ≤ 65 years
    •Diagnostic of active acromegaly based on accepted criteria.
    •If treated with a long acting somatostatin analogue, the treatment has been unchanged for a minimum of 12 weeks.
    •Having IGF-1 serum levels at entry with the following characteristics:
    - If the patient is already treated with Sandostatin LAR® 30 mg: IGF-1 at entry must be normal (less than 10 % above the upper limit of reference range, based on gender and age).
    - If the patient is treated with Sandostatin LAR® 20 mg: any value.
    - If the patient is treated with Sandostatin® immediate release or dopamine agonists*, or not treated: value of IGF-1 at entry must be above 10% of upper limit of reference range, based on gender and age.
    * (A wash out period of a minimum of seven days of dopamine agonists will be needed prior to test drug administration).
    •Having the ability to understand the requirements of the study, provide written informed consent to participate in this study and agree to abide by the study restrictions
    E.4Principal exclusion criteria
    •Female patients of childbearing potential age who are not taking adequate contraception.
    •Pregnant or lactating female patients.
    •Treated with a GH receptor antagonist (pegvisomant) within 12 weeks prior to admission into the study.
    •Had undergone pituitary surgery within six months or radiotherapy within two years prior to admission into the study.
    •Presenting any contra-indication to Sandostatin LAR® treatment, namely hypersensitivity to octreotide or any components of the formulation.
    •Having other conditions that could result in altered GH or IGF-1 levels (severe hepatic or renal disease, anorexia nervosa, Laron’s syndrome, treatment with levodopa or narcotic analgesics, heroin abuse).
    •Presenting signs and symptoms potentially related to a tumor compression of the optical chiasm (unless there are stable sequelae remaining after surgery).
    •Known or suspected contra-indication, allergy, hypersensitivity to the test article ingredients or any allowed study medication.
    •Presenting clinically significant laboratory abnormalities.
    •Having received an investigational drug or participated in a clinical trial within 30 days of study entry.
    •Presenting clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy (with the exception of diabetes mellitus related to acromegaly).
    •Presenting any grossly out-of-range laboratory value (other than noted in Exclusion Criteria, Protocol Section 5.2.2 item #9) unless approved by the Sponsor’s Medical Monitor or by the Principal Consultant.
    •Had undergone any surgery within four weeks of study entry unless approved by the Sponsor’s Medical Monitor or by the Principal Consultant.
    •Presenting an abnormal 12-lead electrocardiogram (ECG) which, in the opinion of the Investigator, is clinically serious, unstable or significant.
    •Presenting with symptomatic biliary lithiasis.
    Presenting any other conditions or prior therapy which, in the opinion of the Investigator, would make the patient unsuitable for this study
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Outcome Measures:
    •Percent changes in IGF-1 serum concentrations at Day 84, when compared to Baseline.
    •Percent changes in GH serum concentrations (mean of three values at one hour interval at each time point) at Day 84, when compared to Baseline.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sandostatin LAR 30 mg
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 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) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-11-20. Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 65
    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 Decision2007-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-27
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