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    Summary
    EudraCT Number:2021-005790-60
    Sponsor's Protocol Code Number:CL-SBP-101-04
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-06-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-005790-60
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare overall survival (OS) between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine
    A.4.1Sponsor's protocol code numberCL-SBP-101-04
    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 SponsorPanbela 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 supportPanbela Therapeutics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPanbela Therapeutics, Inc
    B.5.2Functional name of contact pointMichael Walker, MD
    B.5.3 Address:
    B.5.3.1Street Address712 Vista Boulevard #305
    B.5.3.2Town/ cityWaconia, MN
    B.5.3.3Post code55387
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19524791196
    B.5.6E-mailmwalker@panbela.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 SBP-101
    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 INNSBP-101 tetrahydrochloride
    D.3.9.1CAS number 259657-09-5
    D.3.9.2Current sponsor codeSBP-101
    D.3.9.3Other descriptive nameSBP-101 tetrahydrochloride
    D.3.9.4EV Substance CodeSUB260747
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboInjection/infusion
    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
    Metastatic Pancreatic Ductal Adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Pancreatic Cancer
    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 primary objective of the study is to compare overall survival (OS) between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine.
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare progression free survival (PFS) between SBP-101 and placebo.

    Other Secondary Efficacy:
    To compare objective response rate (ORR) between SBP-101 and placebo
    To compare disease control rate (DCR) between SBP-101 and placebo
    To compare duration of response (DoR) between SBP-101 and placebo
    To compare changes in quality of life (QOL) scores between SBP-101 and placebo
    To compare the safety and tolerability of SBP-101 compared to placebo when administered in combination with nab-paclitaxel and gemcitabine.
    Exploratory:
    To compare the effects of SBP-101 and placebo on blood levels of CA19-9 and circulating tumor DNA (cTDNA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject must meet all of the following inclusion criteria to be eligible for enrollment in this study:
    1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
    2. Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and nab-paclitaxel. Subjects who have had planned or prior surgery, such as a Whipple procedure, with or without neo-adjuvant/adjuvant chemotherapy may be included.
    3. Life expectancy ≥3 months.
    4. Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.
    5. ECOG Performance Status 0-1.
    6. Adult, age ≥ 18 years, male or female.
    7. Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception from 2 weeks before the first administration of SBP-until 6 months after the last administration of the study drug (i.e., last dose of any of the three drugs in the regimen). Female subjects are considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, all with surgery at least one month before dosing). Male subjects with partners who are oCBP should also use a highly effective contraceptive measure during the study and through 6 months following the last administration of study drug. Male subjects are considered of reproductive potential following puberty, unless permanently sterilized by bilateral vasectomy. Male subjects oCBP should be counseled to consider cryogenic preservation of sperm prior to study initiation due to the possibility of infertility post-treatment.
    8. Adequate bone marrow, hepatic, renal, and coagulation function as defined by the following:
    a. Absolute neutrophil count ≥1.5 x 109/L
    b. Hemoglobin ≥9.0 g/dL (90 g/L)
    c. Platelets ≥100 x 109/L
    d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT ≤5 x ULN.
    e. Bilirubin ≤1.5 x ULN
    f. Calculated creatinine clearance using the Cockcroft and Gault equation >50 mL/min
    9. QTc interval of ≤ 470 ms (for women) and ≤ 450 ms (for men) on the ECG baseline calculated by either the Fridericia or Framingham formula.
    10. Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures is required.
    E.4Principal exclusion criteria
    Subjects are excluded from this study if any of the following conditions are met:
    1. When results of germline or somatic testing done prior to screening are known, subjects known to have mutations of the BRCA1/2 (Breast are known, subjects known to have mutations of the BRCA1/2 (Breast Cancer gene). If not done previously as standard of care, testing for mutated BRCA 1/ 2 genes may be initiated at the discretion of the site Investigator, and in parallel, screening and treatment may proceed before the results are known.
    2. Concomitant metformin administration. Diabetic subjects on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic medications are allowed).
    3. Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia [-6.0 diopters or approximately 20/500], eye surgery <6 months prior to C1D1, or history of a severe eye injury). Subjects with findings of retinopathy on baseline ophthalmology exams will be excluded.
    4. Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
    5. Medical or psychiatric conditions that compromise the subject’s ability to give informed consent or to complete the protocol or a history of non-compliance.
    6. Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma.
    7. Symptomatic CNS malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
    8. Serum albumin <30 g/L (3.0 g/dL).
    9. Deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event that occurs during screening. Subjects with events that occurred prior to screening and are on stable therapy are not excluded.
    10. Presence of known active bacterial, fungal, or viral infection requiring systemic therapy.
    11. Known active infection with human immunodeficiency virus (HIV), hepatitis B or C.
    12. Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction.
    13. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV.
    14. Pregnant or lactating.
    15. Major surgery within 4 weeks of the start of study treatment, without complete recovery.
    16. Known hypersensitivity to any component of study drug treatments.
    17. Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug. Participation in observational trials is not excluded.
    18. Any history of hydroxychloroquine use (Plaquenil® and other brand names) within the last 12 months prior to dosing of SBP-101.
    E.5 End points
    E.5.1Primary end point(s)
    OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause.
    The primary efficacy endpoint, OS, and secondary efficacy endpoints of PFS and DoR will be evaluated using log-rank test; hazard ratios (placebo/SBP-101) and 2-sided 90% confidence intervals will be estimated. The difference between treatment groups in ORR will be evaluated using exact test along with 2-sided 90% confidence intervals. The difference in DCR between SBP-101 and placebo will be assessed using the Cochran-Mantel-Haenszel general association test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    OS is defined as the time from randomization (Day 1) until death from any cause (up to 2 years).
    E.5.2Secondary end point(s)
    PFS defined as the time (days) from Study Day 1 until disease progression or death from any cause, whichever occurs first.
    ORR defined as the percentage of subjects with a best overall response of CR or PR, as determined by independent, central assessment using RECIST 1.1 criteria
    DCR defined as the percentage of subjects who have a confirmed CR, confirmed PR, or SD for at least 16 weeks.
    DoR in subjects who achieve a CR or PR, defined as time from onset of first response (CR or PR) until disease progression or death from any cause, whichever occurs first. This endpoint is undefined for subjects who do not achieve a CR or PR.
    QOL assessed using EORTC QLQ-30 and QLQ-PAN26 questionnaires.
    TEAEs
    • Clinically important changes in safety laboratory tests and vital signs.
    • Changes in response to a vision-centered questionnaire and serial ophthalmologic examinations.

    Exploratory:
    • Proportion of subjects with any CA19-9 decrease from baseline, CA19-9 decrease at Week 8, and maximum CA19-9 decrease ≥60%.
    • Blood levels of cTDNA biomarkers. Note all ctDNA collection will be halted at interim analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See 5.1.1
    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 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) Yes
    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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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
    Australia
    Korea, Republic of
    United Kingdom
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Spain
    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
    Unless the trial enrollment is stopped for futility after the interim futility analysis, the study is completed when the required total of 512 OS events have been observed, hence, study duration is driven by the occurrence of the pre-specified number of OS events. All enrolled subjects will be followed for OS until the end of study or death, whichever occurs first.
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state69
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 600
    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 Decision2022-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-02
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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