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    Summary
    EudraCT Number:2022-000762-18
    Sponsor's Protocol Code Number:CRN00808-11
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-000762-18
    A.3Full title of the trial
    A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome
    A.4.1Sponsor's protocol code numberCRN00808-11
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05361668
    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 SponsorCrinetics Pharmaceuticals, 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 supportCrinetics Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCrinetics Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointCrinetics Clinical Trials
    B.5.3 Address:
    B.5.3.1Street Address10222 Barnes Canyon Road, Bldg #2
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@crinetics.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.3.1Product namePaltusotine
    D.3.4Pharmaceutical form Tablet
    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 INNPaltusotine
    D.3.9.2Current sponsor codeCRN00808
    D.3.9.3Other descriptive namePaltusotine
    D.3.9.4EV Substance CodeSUB205549
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaltusotine
    D.3.9.2Current sponsor codeCRN00808
    D.3.9.3Other descriptive namePaltusotine
    D.3.9.4EV Substance CodeSUB205549
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Carcinoid Syndrome
    E.1.1.1Medical condition in easily understood language
    A rare tumor that secretes chemicals in the blood that can cause a variety of symptoms such as diarrhea and flushing
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007270
    E.1.2Term Carcinoid syndrome
    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
    Safety: To evaluate the safety and tolerability of paltusotine at 40, 80, and 120 mg QD doses
    Pharmacokinetics: To assess the PK of 40, 80, and 120 mg paltusotine
    E.2.2Secondary objectives of the trial
    Not Applicable - please refer to Protocol for list of Exploratory Efficacy objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent prior to any
    study related procedures.
    2. Willing and able to comply with the study procedures as specified in
    the protocol, including at least 70% compliance with electronic symptom
    diary for the 2 week period prior to the S2 visit and prior to the Day 1
    visit.
    3.Male or female subjects ≥18 years of age, at the time of Screening.
    4.Documented carcinoid syndrome requiring medical therapy. Eligible
    subjects fall into one of the following categories:
    •Not currently treated with SRL agonists for at least 12 weeks prior to
    screening, and actively symptomatic (average of ≥4 BM/day or >2
    flushing episodes per day in at least 2 days over a period of 2 weeks).
    This can include treatment-naïve subjects.
    •Subjects currently treated with lanreotide, octreotide LAR, or short
    acting octreotide (subcutaneous or oral) who are currently
    symptomatically controlled (average <4 BM/day and average ≤2
    flushing episodes/day over a 2 week period) and willing to wash out of their medication. The subject must demonstrate symptomatic worsening
    after washout. These subjects must have at least one historical instance
    of an elevated 5-HIAA or serotonin level.
    5. Evaluable documentation of locally advanced or metastatic
    histopathologically confirmed well-differentiated NET. Tumors must be
    Grade 1 or Grade 2 (Ki-67 index ≤20%, or a mitotic count of ≤20
    mitoses per 10 high-power fields, if the Ki-67 index is not available) per
    the World Health Organization neuroendocrine neoplasm classification.
    Grade 3 tumors are not eligible.
    6. No significant disease progression as assessed by the Investigator
    within the last 6 months before initiation of study drug dosing.
    7. Historical documentation of positive SSTR tumor status by PET or
    somatostatin receptor scintigraphy
    8. Plasma 5-HIAA ≥2× ULN during Screening for subjects not currently
    treated with any SRL therapy who are not washing out of SRLs.
    9.Females who engage in heterosexual intercourse must be of
    nonchildbearing potential, defined as either surgically sterile (ie,
    hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR
    be postmenopausal with at least 1 year of amenorrhea, OR must agree to
    use a highly effective method of contraception from the beginning of
    Screening to the last study visit.
    •Acceptable highly effective methods of contraception include:
    - Combined estrogen-progestin oral hormonal contraception associated
    with consistent inhibition of ovulation
    - Desogestrel-based progestin only contraception associated with
    consistent inhibition of ovulation; this includes oral, injectable, and
    implantable methods
    - Intravaginal and transdermal hormone delivery methods
    - Intrauterine device (with or without hormone elution)
    - Bilateral tubal occlusion or ligation (must be documented)
    - Vasectomized partner (must be documented) or
    - Sexual abstinence (only when it is the usual and preferred lifestyle of
    the subject)
    In addition to these methods of contraception, the male partner should
    use a condom from the beginning of Screening to the last study visit.
    10. If the subject is male, the subject should agree to use a condom
    when sexually active with a female partner of childbearing potential
    from Screening until at least 30 days after the last dose of study drug or
    be surgically sterile [ie, vasectomy with documentation]; or remain
    abstinent [when this is in line with the preferred and usual lifestyle].
    Male subjects should also agree to not donate sperm for the duration of
    the study and until at least 30 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1.Diarrhea attributed to any condition(s) other than carcinoid syndrome
    (including but not limited to fat malabsorption, bile acid malabsorption,
    short bowel syndrome, pancreatic exocrine insufficiency, infections,
    VIPoma, Zollinger-Ellison syndrome). Exception to this are subjects with
    prior cholecystectomy or small bowel resections, provided diarrhea is
    controlled prior to washout or if not currently treated with any SRL
    therapy.
    2.Uncontrolled/severe diarrhea associated with significant volume
    contraction, dehydration, or hypotension.
    3.Requires second line treatments (eg, telotristat) for control of
    carcinoid syndrome symptoms in the opinion of the Investigator.
    4.Treatment with specific NET tumor therapy <4 weeks before Screening
    (such as everolimus or sunitinib) or hepatic embolization, radiotherapy,
    peptide receptor radionuclide therapy (PRRT), and/or tumor debulking <12 weeks before Screening.
    5. Karnofsky performance status <60%.
    6. Major surgery within 8 weeks before Screening.
    7. History of another primary malignancy <3years prior to the date of first dose of study treatment unless at least one of the following criteria are met:
    •Adequately treated basal or squamous cell carcinoma of the skin
    •Cancer of the breast or cervix in situ
    •Previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease.
    •Concurrent malignancy determined to be clinically stable and not
    requiring treatment.
    8. Life expectancy <12 months from Screening.
    9. Diabetes mellitus treated with insulin for less than 6 weeks prior to
    the study entry.
    10. Poorly controlled diabetes mellitus defined as having a hemoglobin
    A1c (HbA1c) ≥8.5% (ie, ≥69.5 mmol/mol) or estimated HbA1c based on
    fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathy).
    11. History of unstable angina or acute myocardial infarction within the
    12 weeks preceding the Screening Visit or other clinically significant
    cardiac disease (including clinically significant carcinoid heart disease)
    at the time of Screening as judged by the Investigator.
    12. Known history of, or current alcohol or drug abuse, within the last
    year.
    13. Concomitant mental condition rendering him/her unable to
    understand the nature, scope, and possible consequences of the study,
    and/or evidence of poor compliance with medical instructions.
    14. Current use of medications that are strong inducers of cytochrome
    P450 3A4 (CYP3A4) (including but not limited to carbamazepine,
    enzalutamide, mitotane, phenytoin, rifampin, St. John's wort) within 2
    weeks prior to Screening because they may reduce systemic exposure to
    paltusotine.
    Current use of medications that are sensitive substrates of CYP3A4 with
    a narrow therapeutic index (including but not limited to tolvaptan,
    lomitapide, pimozide, dronedarone, dasatinib, sirolimus) as paltusotine
    may increase exposure of these medications.
    15. Unable to administer short-acting octreotide (octreotide acetate
    injection), or prior nonresponse documented with somatostatin agonists.
    16. Known allergy or hypersensitivity to any of the test materials or
    related compounds.
    17. Active COVID-19 confirmed or suspected based on SARS-CoV-2
    testing and clinical symptoms.
    18. QT interval corrected using Fridericia's formula (QTcF) >480 msec
    (or QTcF >500 msec in the presence of complete bundle branch block) or
    PR interval >240 msec during Screening based on a central reading of an
    average of 3 ECGs each separated in time by approximately 1 minute
    after the subject has rested quietly in the supine position for at least 10
    minutes without significant stimulation (noise, television, etc.).
    19. Clinically significant concomitant disease that is not a result of primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate <30 mL/min/1.73 m2, cirrhosis, baseline AST and/or ALT >2× ULN, and/or total bilirubin >1.5× ULN. (Subjects with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin <3.5 mg/dL [<51.3 µmol/L] will be permitted.)
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from Baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose)
    Pharmacokinetics: Steady state trough levels at each dose at EOR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: from Baseline to the EOR
    Pharmacokinetics: EOR
    E.5.2Secondary end point(s)
    Not Applicable - please refer to Protocol for list of Exploratory Efficacy endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable - please refer to Protocol for timepoints for evaluation of Exploratory Efficacy endpoints
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    other doses of the same product
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Argentina
    Peru
    Brazil
    Canada
    Mexico
    United States
    Poland
    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
    last visit of the last subject on the study
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 30
    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 Randomized Treatment Phase, subjects may be eligible to enter the optional Open-Label Extension (OLE) Phase of the study in which they will receive paltusotine for a total duration of treatment up to 110 weeks or up to 28 months.
    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 Decision2023-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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