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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003739-32
    Sponsor's Protocol Code Number:1801
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-07
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2018-003739-32
    A.3Full title of the trial
    Actuate 1801: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematological Malignancies or Solid Tumors.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of a new drug known as 9-ING-41, that will take place in
    patients with tumors or cancers that affect the blood and lymph system.
    9-ING-41 will be assessed as a standalone drug as well as being assessed
    when taken with chemotherapy drugs
    A.3.2Name or abbreviated title of the trial where available
    Actuate 1801: Phase 1/2 of 9-ING-41 in Refractory Malignancies
    A.4.1Sponsor's protocol code number1801
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03678883
    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 SponsorActuate 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 supportActuate Therapeutics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncology Therapeutic Development
    B.5.2Functional name of contact point1801 Project Manager
    B.5.3 Address:
    B.5.3.1Street Address100 rue Martre
    B.5.3.2Town/ cityClichy
    B.5.3.3Post code92110
    B.5.3.4CountryFrance
    B.5.4Telephone number+33147150101
    B.5.6E-mailotd@oncotd.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 nameElraglusib (9-ING-41)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN9-ING-41
    D.3.9.1CAS number 1034895-42-5
    D.3.9.3Other descriptive name3-(5-fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5 f]indol-7-yl)-1H-pyrrole-2,5-dione
    D.3.9.4EV Substance CodeSUB197944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Refractory Hematologic Malignancies or Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Advanced Cancers
    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 PT
    E.1.2Classification code 10066476
    E.1.2Term Haematological malignancy
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Only part 3B objective is listed:

    • To determine the 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in stage of the study compared to the control arm.
    E.2.2Secondary objectives of the trial
    Only part 3B objectives are listed:

    • To determine the rate of disease control of the combination of 9-ING-41 and gemcitabine/nab-paclitaxel (GA) in patients with pancreatic cancer without prior systemic therapy for advanced disease.
    • To correlate disease control rate with tumor molecular profiles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only Part 3B criteria are listed:

    1. Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
    2. Is aged ≥ 18 years
    3. Has pathologically or cytologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting AND would be a candidate to receive gemcitabine/nab-paclitaxel as a first-line treatment
    4. Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)
    5. Has laboratory function within specified parameters (may be repeated):
    a. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL
    b. Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN); bilirubin ≤ 1.5 x ULN
    c. Adequate renal function: serum creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min for patients with a serum creatinine >ULN (calculated by the Cockcroft and Gault formula)
    6. Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1
    7. Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug:
    • Focal radiation therapy – 7 days
    • Surgery with general anesthesia – 7 days
    • Surgery with local anesthesia – 3 days
    8. May have received treatment with fluorouracil or gemcitabine as a radiation sensitizer in the adjuvant setting if the treatment was received at least 6 months before study enrollment
    9. Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 6 months after discontinuation of study treatment
    10. Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 3 months after discontinuation of study treatment and use appropriate barrier contraception or true abstinence
    11. Must not be receiving any other investigational medicinal product
    E.4Principal exclusion criteria
    Only Part 3B criteria are listed:

    1. Is pregnant or lactating
    2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation
    3. Has endocrine or acinar pancreatic carcinoma
    4. Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and/or infertility. Recovery is defined as ≤ Grade 2 severity per CTCAE, v5.0
    5. Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of study therapy, or uncontrolled cardiac arrhythmia
    6. Has had a myocardial infarction within 12 weeks of the first dose of study therapy or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator
    7. Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Patients with stable brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
    8. Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major)
    9. Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation.
    10. Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.
    11. Has a current active malignancy other than pancreatic cancer
    12. Is considered to be a member of a vulnerable population (for example, prisoners).
    E.5 End points
    E.5.1Primary end point(s)
    Only part 3B endpoint is listed:

    • 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in portion of the study compared to the control arm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year from the first dose of protocol anticancer medications
    E.5.2Secondary end point(s)
    Only part 3B endpoints are listed:

    • Disease control rate (DCR), defined as: Stable disease for ≥16 weeks, confirmed complete response, or confirmed partial response.
    • Objective response rate (ORR), defined as the percent of patients with Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria relative to the efficacy population.
    • Duration of Response (DOR), defined as the time from documentation of tumor response to disease progression
    • Progression-Free Survival (PFS), defined as the time from study enrolment until objective tumor progression or death
    • OS, defined as the time from study entry to death from any cause
    • Time to Treatment Failure (TTF)
    • Adverse events will be monitored from the date of first administration of 9 ING-41 and ending 30 days after the final administration of 9-ING-41 using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0
    • Correlation of disease control rate with tumor molecular profiles
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time-to event endpoints (DoR, PFS, and OS) assessed from documentation of tumor response to disease progression, from study enrolment until objective tumor progression or death or from study entry to death from any cause respectively.
    Adverse events will be monitored during the period starting on the date of receipt of first administration of 9-ING-41 and ending 30 days after the final administration of 9-ING-41
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    United States
    France
    Poland
    Netherlands
    Spain
    Switzerland
    Germany
    Italy
    Belgium
    Hungary
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months7
    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: 341
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 171
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 512
    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)
    Part 3B:

    All randomized patients will also be followed for survival every 3 months until all patients have died or the last patient enrolled has been followed for 1 year after their last dose of study drug. If a patient has withdrawn consent or is no longer being followed prior to their date of death, the date of death will be determined and documented based on public records.
    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 Decision2023-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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