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    Summary
    EudraCT Number:2017-000737-31
    Sponsor's Protocol Code Number:OOC-ACM-303
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-000737-31
    A.3Full title of the trial
    A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of octreotide capsules in patients who previously tolerated and demonstrated biochemical control on injectable somatostatin receptor ligands (SRL) treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study (late stage development study), that compares the efficacy and safety of oral octreotide capsules to placebo in acromegaly patients
    A.3.2Name or abbreviated title of the trial where available
    OPTIMAL
    A.4.1Sponsor's protocol code numberOOC-ACM-303
    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 SponsorChiasma, Inc.
    B.1.3.4CountryUnited States
    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 supportChiasma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiasma, Inc.
    B.5.2Functional name of contact pointRegulatory Department (Dina Coll)
    B.5.3 Address:
    B.5.3.1Street Address460 Totten Pond Road, Suite 530
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+972 50-207-1754
    B.5.6E-maildinac@chiasmapharma.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 numberEU/3/13/1170
    D.3 Description of the IMP
    D.3.1Product nameMycapssa®
    D.3.4Pharmaceutical form Capsule
    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.3.8INN - Proposed INNOctreotide acetate
    D.3.9.1CAS number 79517-01-4
    D.3.9.3Other descriptive nameOCTREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB03490MIG
    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.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
    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
    Acromegaly
    E.1.1.1Medical condition in easily understood language
    Acromegaly is a hormonal disorder mainly resulting from a tumor in the pituitary gland, leading to excess of growth hormone
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.2System Organ Class 10014698 - Endocrine disorders
    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 maintenance of biochemical control with octreotide capsules compared to placebo in patients with acromegaly, who previously demonstrated biochemical control on SRLs
    E.2.2Secondary objectives of the trial
    _To assess maintenance of biochemical control, based on GH, with octreotide capsules compared to placebo.
    _To evaluate the safety profile of octreotide capsules compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult subjects, aged ≥18 years old at the first Screening visit.
    2. Patients with active acromegaly, defined as documented evidence of GH-secreting pituitary tumor based on MRI/Pathology report and documented evidence of IGF-1 levels ≥1.3 × ULN. This needs to be at least 3 months following pituitary surgery in
    those patients who had prior pituitary surgery.
    3. Received parenteral SRL monotherapy (octreotide or lanreotide but not pasireotide) for at least 6 months with a stable dose for at least the last three months of therapy.
    4. Average IGF-1 of 2 assessments obtained during the Screening period is ≤1 * ULN.
    5. Patients able and willing to comply with the requirements of the protocol at the time of Screening.
    6. Women who are of childbearing potential should use an acceptable method for birth control. Acceptable methods include hormonal contraception (oral contraceptives – as long as on stable dose, patch, implant, and injection), intrauterine devices, or double
    barrier methods (e.g. vaginal diaphragm/ vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Women taking oral contraception containing levonorgestrel should either change treatment (at least one month prior to first study medication dose) or use a mechanical barrier method.
    7. Patients able to understand and sign written informed consent to participate in the study.
    E.4Principal exclusion criteria
    1. Patients taking injections of long-acting SRLs off label (unlabeled doses or dosing interval. e.g. 60 or 90 mg lanreotide every 8 weeks or 30 mg octreotide every 6 or 8 weeks).
    2. Patients who previously participated in CH-ACM-01 or OOC-ACM-302 (MPOWERED).
    3. Symptomatic cholelithiasis.
    4. Conventional or stereotactic Radiotherapy any time in the past.
    5. Undergone pituitary surgery within six months prior to screening or have elective pituitary surgery (or other elective surgery that may affect compliance with protocol or confound study outcomes), planned within the course of the core study.
    6. High-risk pattern of pituitary tumor location on pituitary magnetic resonance imaging (MRI)/Computed tomography (CT) as per medical history or most recent MRI/CT.
    7. History of unstable angina or acute myocardial infarction within the 12 weeks preceding the screening visit or other clinically significant cardiac disease at the time of screening as judged by the Principal Investigator.
    8. Any clinically significant uncontrolled nervous system, gastrointestinal (GI), renal, pulmonary, or hepatic concomitant disease that in the Investigator’s opinion would preclude patient participation.
    9. Evidence of active malignant disease or malignancies diagnosed within the previous one year (except for basal cell carcinoma and uncomplicated – up to stage 1 squamous cell carcinoma that has been excised and cured).
    10. Known allergy or hypersensitivity to any of the test compounds or materials.
    11. Known uncontrolled diabetes defined as having a fasting glucose > 150 mg/dL (8.3 mmol/L) or glycosylated hemoglobin (HbA1c) ≥ 8% (patients can be rescreened after diabetes is brought under adequate control, or in case HbA1c < 8%).
    12. Known defects in visual fields due to optic chiasmal compression or other neurological signs, related to the pituitary tumor mass. Patients with long-standing (>12 months), fixed, minor defects may be considered on a case-by-case basis after consultation with the
    medical monitor.
    13. Female patients who are pregnant or lactating or intending to become pregnant during the study.
    14. Known history of immunodeficiency (e.g., HIV positive).
    15. ALT, AST or ALP > 3 * ULN or Total Bilirubin >1.5 * ULN.
    16. Undergone major surgery/surgical therapy for any cause within four weeks prior to enrollment or planned procedure during the study.
    17. Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or steroid hormone replacement therapy for ≥ 12 weeks.
    18. Any condition that may jeopardize study participation (e.g., clinically significant abnormal screening clinical or laboratory finding during screening), the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition).
    19. History of illicit drug or alcohol abuse within five years.
    20. Intake of an investigational drug within 30 days prior to initiation of study treatment.
    21. Treatment with pegvisomant within 24 weeks before the first screening visit.
    22. Treatment with dopamine agonists within 12 weeks before the screening visit.
    23. Treatment with pasireotide within 24 weeks before the first screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients who maintain their biochemical response at the end of the DPC period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maintenance of response will be defined by using the average IGF-1 level of the last 2 available assessments between weeks 34 and 36 in the DPC period. If the average IGF-1 is ≤ 1 × ULN, a patient will be classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is > 1 × ULN, a patient will be classified as a non-responder. Patients who discontinue study
    medication during the DPC period for any reason will be classified as nonresponders for the primary analysis, regardless of their IGF-1 values.
    E.5.2Secondary end point(s)
    _Proportion of patients who maintain GH response (i.e., GH < 2.5 ng/mL) at week 36, out of those who were responders (i.e., GH < 2.5 ng/mL) on SRL injections at Screening. GH response will be defined using the mean integrated GH value, based on 5 assessments, 30 minutes apart. Patients who discontinue treatment during the DPC period for any reason will be classified as non-responders, regardless of their IGF-1 values.
    _Time to loss of response: Loss of response is defined as the earliest time when the IGF-1 of 2 consecutive visits is > 1×ULN, after the patient is treated for at least 2 weeks with 4 capsules per day.
    _Time to loss of response: Loss of response is defined as the earliest time when the IGF-1 of 2 consecutive visits is > 1.3×ULN, after the patient is treated for at least 2 weeks with 4 capsules per day
    _Proportion of patients who begin rescue treatment prior to and including week 36.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline from end of treatment
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 EEA30
    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
    Canada
    Denmark
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Poland
    Romania
    Sweden
    Turkey
    United Kingdom
    United States
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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)
    Following completion of the 36-week core study, patients will be offered to enter the Open-Label Extension period and receive octreotide capsules until the last patient enrolled into the OLE completes one year or until product marketing or study termination by the sponsor. Once the last patient enrolled completes one year, the Sponsor may either extend the OLE period or consider compassionate use
    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 Decision2017-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
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