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    Summary
    EudraCT Number:2019-003142-32
    Sponsor's Protocol Code Number:TBR-760-NFPA-201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-003142-32
    A.3Full title of the trial
    A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients with Non-Functioning Pituitary Adenomas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the safety, tolerability and efficacy of TBR-760 in patients with Non-Functioning Pituitary Adenomas
    A.4.1Sponsor's protocol code numberTBR-760-NFPA-201
    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 SponsorTiburio Therapeutics, 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 supportTiburio Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTiburio Therapeutics, Inc.
    B.5.2Functional name of contact pointNerissa Kreher
    B.5.3 Address:
    B.5.3.1Street Address700 Technology Square, 2nd Floor
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617949-6239
    B.5.6E-mailNKreher@TIBURIO.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code TBR-760
    D.3.4Pharmaceutical form Solution for injection
    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 INNTBR-760
    D.3.9.1CAS number 778630-77-6
    D.3.9.2Current sponsor codeTBR-760
    D.3.9.3Other descriptive nameTBR-760 triacetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Functioning Pituitary Adenomas
    E.1.1.1Medical condition in easily understood language
    Non-Functioning brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10035079
    E.1.2Term Pituitary adenoma
    E.1.2System Organ Class 100000004864
    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 the safety and tolerability of TBR-760 in adult patients with non-functioning pituitary adenomas (NFPAs)
    To assess the effect of TBR-760 on tumor remnant shrinkage in adult patients with NFPAs
    E.2.2Secondary objectives of the trial
    To characterize the pharmacokinetic (PK) profile of TBR-760 in adult patients with NFPAs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, ≥18 or ≤80 years of age;
    2. Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS;
    3. At the time of Screening, must have NFPA remnant following TSS of ≥10mm (maximum diameter) based on locally read MRI performed ≤24 months ago;
    4. Female patients must not be pregnant and be highly unlikely to become pregnant. Male patients
    must be unlikely to impregnate a partner. Male or female patients must meet at least one of the following criteria:
    a. A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who: (1) has reached natural menopause (defined as 12 months of spontaneous amenorrhea without an alternative medical cause except if the medical cause is related to the NFPA or previous treatment of the NFPA including TSS); (2) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (3) has undergone bilateral tubal ligation.
    b. A male patient who is not of reproductive potential is eligible without requiring the use of contraception. A male patient who is not of reproductive potential is defined as one who has undergone a successful vasectomy or has hypogonadism and is on androgen replacement. A successful vasectomy is defined as (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
    5. A male or female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) acceptable methods of highly effective contraception starting from the time of consent through 3 months after the completion of study therapy. True abstinence is defined as abstinence that is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the study and withdrawal are not acceptable methods of contraception. Female patients must agree to two forms of birth control. Acceptable methods of highly effective birth control are combined or progestogen-only hormonal contraception that is associated with inhibition of ovulation, intrauterine device, and intrauterine hormone-releasing system. Female patients using a hormonal method of contraception must be accompanied with the use of a second, non-hormonal method of contraception (e.g. condom).
    6. On a stable dose of hormone replacement therapy (i.e., growth hormone, thyroid hormone, corticosteroid, or sex hormone) for at least 3 months prior to Screening, if applicable.
    7. Patients receiving treatment for hypertension must be controlled on a stable dose for at least one month, in the opinion of the Investigator, prior to Screening.
    8. Be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained by the Investigator or Investigator designee.
    9. Be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff.
    E.4Principal exclusion criteria
    1. Has undergone more than one TSS, or had TSS <6 months prior to screening, or is anticipated to require TSS within 6 months of Screening;
    2. Is likely to, in the opinion of the Investigator, require TSS or radiation during the course of the study due to location of (i.e., remnant anatomically impinging upon the optic chiasm), or growth rate of the remnant;
    3. Is known to have silent corticotroph, somatotroph or thyrotroph adenoma;
    4. Has undergone radiation therapy to the head for any reason, or is already planned to have or anticipated to require radiation therapy during the study period;
    5. Prior treatment with any dopamine receptor agonist or somatostatin analog (administration of single doses for testing purposes is acceptable);
    6. Has been or is currently being treated for psychotic disorder and/or requires neuroleptic antipsychotic/prokinetic (antiemetic) drugs (i.e., butyrophenones, phenothiazines, metoclopramide), due to antagonism of neuroleptic and dopaminergic agonists;
    7. Any contraindications to magnetic resonance imaging including allergy or intolerance to gadolinium or gadolinium-based contrast;
    8. Any history of clinically severe cardiac valvular disease;
    9. Has history of clinically significant orthostatic hypotension or severe hypotension.
    10. Positive for human immunodeficiency virus (HIV), hepatitis C (HCV) antibodies (unless the patient has successfully completed drug therapy that results in cure/clearance of HCV), and hepatitis B surface antigen (HBsAg);
    11. For female patients of childbearing potential, a positive serum human chorionic gonadotropin (hCG) test or a positive urine hCG test on Screening or Day 1;
    12. Planning to become pregnant or to breastfeed during the study or is currently breastfeeding;
    13. Has clinically significant hepatic abnormalities in the opinion of the investigator or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal (ULN); total bilirubin > 2x the upper limit of normal. Patients with Gilbert’s syndrome are excluded.
    14. Has clinically significant renal disease in the opinion of the Investigator or estimated glomerular filtration rate (eGFR) < 60 mL/min.
    15. Has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8%);
    16. Body Mass Index (BMI) <17.5 or >40 kg/m2;
    17. A history of drug or alcohol abuse within the past one year as judged by the Investigator.
    18. A cancer that has not been in complete remission for at least 5 years. Patients with squamous cell or basal cell carcinoma of the skin, localized cervical cancer, or localized prostate cancer are eligible if, in the opinion of the Investigator, the condition has been adequately diagnosed, and is determined to be clinically in remission, and the patient’s participation in the study would not represent a safety concern.
    19. A history of a clinically significant allergic reaction or hypersensitivity, as judged by the Investigator, to any drug or any component of the study drug formulations used in the study.
    20. On electrocardiogram (ECG), a corrected QT interval, Fridericia’s formula (QTcF) >450 ms in men and >470 ms in women or the presence of clinically significant abnormalities as determined by the investigator.
    21. A history of major surgery within 4 weeks or minor surgery within 2 weeks of Day 1.
    22. Any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or vaccination with attenuated live virus within 4 weeks of Day 1.
    23. Participation in an investigational drug or device study within 30 days prior to Day 1.
    24. Other prior or ongoing medical condition, physical findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the patient, make it unlikely that the course of treatment or follow-up would be completed, or impair the assessment of study results.
    25. In the opinion of the Investigator, the patient is unable to meet the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    TBR-760 safety and tolerability as measured by:
    o Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
    o Change from baseline in 12-lead ECG parameters, clinical laboratory tests (chemistry, hematology, HbA1c, fasting blood glucose, coagulation, urine), gallbladder echography, and vital signs
    o Physical examination findings
    • The percentage of patients who have tumor remnant shrinkage at 52 weeks as measured by change in the calculated tumor volume
    E.5.1.1Timepoint(s) of evaluation of this end point
    at weeks 13, 26 and 52
    E.5.2Secondary end point(s)
    • The plasma PK profile of TBR-760 after SC administration in adult patients with NFPAs
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the following timepoints: 0.5, 1, 2, 6, 8, 12, 24, 48, 72, 120, and 168 hours after dose administration at Day 1 and Week 26
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Bulgaria
    Czech Republic
    France
    Georgia
    Germany
    Hungary
    Israel
    Netherlands
    Poland
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 150
    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)
    All patients who successfully complete the study will be offered inclusion in an open-label extension study
    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 Decision2020-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-28
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