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    Summary
    EudraCT Number:2022-002801-36
    Sponsor's Protocol Code Number:Can-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-002801-36
    A.3Full title of the trial
    A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined with Conventional Concurrent Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma
    Estudio abierto de fase I/II para evaluar la seguridad y la evidencia preliminar de un efecto terapéutico de azeliragon combinado con radiación concurrente convencional y temozolomida en pacientes con glioblastoma de reciente diagnóstico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Azeliragon in Glioblastoma
    Azeliragon en Glioblastoma
    A.4.1Sponsor's protocol code numberCan-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 SponsorCantex 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 supportCantex Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMfar Clinical Research
    B.5.2Functional name of contact pointFederico Nepote
    B.5.3 Address:
    B.5.3.1Street AddressC/ Balmes 243. Escalera A 5º1ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08006
    B.5.3.4CountrySpain
    B.5.6E-mailinvestigacion@mfar.net
    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 nameAzeliragon
    D.3.2Product code TTP488
    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 INNAzeliragon
    D.3.9.2Current sponsor codeTTP488
    D.3.9.4EV Substance CodeSUB223560
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed glioblastoma
    Glioblastoma de reciente diagnóstico
    E.1.1.1Medical condition in easily understood language
    Glioblastoma
    Glioblastoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    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
    To assess the recommended phase 2 dose (RP2D) of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide.
    Evaluar la dosis de fase 2 recomendada (RP2D) de azeliragon en pacientes con glioblastoma de reciente diagnóstico que reciben radiación y temozolomida concomitante.
    E.2.2Secondary objectives of the trial
    Secondary Endpoints: To determine preliminary evidence of an effect of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide.
    The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
    Disease control as indicated by RANO criteria
    Progression-free survival (PFS)
    Overall survival
    Change in ECOG status (Appendix A)
    Changes in requirement of dexamethasone to control peritumoral edema
    Determinar la eficacia preliminar de azeliragon en pacientes con glioblastoma recién diagnosticado que reciben radiación y temozolomida concomitante.
    La frecuencia de eventos adversos (EA) y eventos adversos graves (EAG) caracterizados por tipo, gravedad (según lo define NCI CTCAE, versión 5.0), gravedad, duración y relación con el tratamiento del estudio.
    Control de la enfermedad según lo indicado por los criterios RANO.
    Supervivencia libre de progresión (SLP).
    Supervivencia global (SG).
    Cambio en el estado de ECOG.
    Cambios en el requerimiento de dexametasona para controlar el edema peritumoral.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To determine if response to RAGE inhibitors could be predicted by a liquid biopsy measuring circulating levels of S100A9 or other molecular biomarkers in the blood.
    Determinar si la respuesta a los inhibidores de RAGE podría predecirse mediante una biopsia líquida que mide los niveles circulantes de S100A9 u otros biomarcadores moleculares en la sangre.
    E.3Principal inclusion criteria
    Patient must have histologically confirmed newly diagnosed glioblastoma (GBM, WHO grade IV). The histological diagnosis must have been made after biopsy or neurosurgical tumor resection.
    Note: Patients should be IDH wild type diagnosed locally
    The local MGMT report determination should be available and should be uploaded to the eCRF.
    Patient should have had a gross total or subtotal resection performed < 7 weeks prior to enrollment, documented at postoperative MRI. Patients who have had a biopsy only without resection are not eligible.
    Patient deemed suitable by the treating physician to receive the standard radiotherapy regimen in combination with temozolomide.
    Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 70 years of age.
    Patient may have received and continue to receive corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization
    Patient has not received prior chemotherapy or radiotherapy.
    Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0: Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; Platelet count ≥ 75,000/mm3 (75 × 109/L); Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support
    Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment) and at Baseline-Day 0:
    AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN). Total bilirubin ≤ 1.5 × ULN.
    Estimated creatinine clearance of > 60 mL/min (per Cockroft-Gault formula)
    Patients with a QTC of ≤ 480 msec
    Patient has ECOG performance status of ≤ 2 (Appendix A)
    Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
    El paciente debe tener glioblastoma recién diagnosticado confirmado histológicamente (GBM, grado IV de la OMS). El diagnóstico histológico debe haberse realizado tras biopsia o resección tumoral neuroquirúrgica.
    Nota: Los pacientes deben ser diagnosticados localmente con IDH-nativo.
    La determinación del informe del MGMT local debe estar disponible y debe cargarse en el eCRF.
    El paciente debe haber tenido una resección total o subtotal macroscópica realizada < 7 semanas antes de la inscripción, documentada en la resonancia magnética postoperatoria. Los pacientes a los que solo se les ha realizado una biopsia sin resección no son elegibles.
    Paciente considerado apto por el médico tratante para recibir el régimen estándar de radioterapia en combinación con temozolomida.
    Varón o mujer no embarazada y no lactante y de ≥ 18 a ≤ 70 años de edad.
    El paciente puede haber recibido y continuar recibiendo corticosteroides, pero debe estar en una dosis estable o decreciente durante al menos 14 días antes de la aleatorización.
    El paciente no ha recibido quimioterapia o radioterapia previa.
    El paciente tiene parámetros biológicos adecuados, como lo demuestran los siguientes hemogramas en la selección (obtenidos ≤ 14 días antes de la inscripción) y en el día 0 inicial: recuento absoluto de neutrófilos (RAN) ≥ 1,0 × 109/L; Recuento de plaquetas ≥ 75.000/mm3 (75 × 109/L); Hemoglobina (Hgb) ≥ 9 g/dL sin transfusión o apoyo con factor de crecimiento
    El paciente tiene los siguientes niveles de bioquímica sanguínea en la selección (obtenidos ≤ 14 días antes de la inscripción) y en el día 0 inicial:
    AST (SGOT), ALT (SGPT) ≤ 2,5 × límite superior del rango normal (LSN). Bilirrubina total ≤ 1,5 × LSN.
    Depuración de creatinina estimada > 60 ml/min (según la fórmula de Cockroft-Gault)
    Pacientes con un QTC de ≤ 480 ms
    El paciente tiene un estado funcional ECOG de ≤ 2
    El paciente ha sido informado sobre la naturaleza del estudio, ha aceptado participar en el estudio y ha firmado el Formulario de consentimiento informado (CI) antes de participar en cualquier actividad relacionada con el estudio.
    E.4Principal exclusion criteria
    Patients will not be eligible to participate in this study if any of the following criteria apply:
    Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years
    Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment
    Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
    Patients who have had treatment with any investigational cancer drug prior to randomization
    Patient has experienced an increase of ECOG to > 2 between Screening and the time of first dose with azeliragon. (Appendix A)
    Patients receiving CYP 2C8 inhibitors noted in Section 5.3
    Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.
    Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
    Females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of azeliragon.
    Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 14 days of starting azeliragon. Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
    Los pacientes no serán elegibles para participar en este estudio si cumplen alguno de los siguientes criterios:
    Pacientes con antecedentes de otras neoplasias malignas, excepto: cáncer de piel no melanoma tratado adecuadamente, cáncer de cuello uterino in situ tratado de forma curativa u otros tumores sólidos tratados de forma curativa sin evidencia de enfermedad durante > 5 años
    Pacientes con una infección activa grave (como una infección de una herida que requiere antibióticos parenterales) en el momento de la aleatorización u otras afecciones médicas subyacentes graves que podrían afectar la capacidad del paciente para recibir el tratamiento del protocolo.
    Pacientes con cualquier condición (p. ej. psicológica, geográfica, etc.) que no permita el cumplimiento del protocolo.
    Pacientes que han recibido tratamiento con cualquier medicamento contra el cáncer en investigación antes de la aleatorización
    El paciente experimentó un aumento de ECOG a > 2 entre la selección y el momento de la primera dosis con azeliragon.
    Pacientes que reciben inhibidores de CYP 2C8.
    El paciente no quiere o no puede cumplir con los procedimientos del estudio, incluidos, entre otros, la autoadministración de medicamentos orales.
    Pacientes con una afección gastrointestinal que podría interferir con la deglución o la absorción.
    Mujeres en edad fértil que sean sexualmente activas o hombres con parejas femeninas en edad fértil, cuando la mujer o el hombre no estén dispuestos a utilizar un método anticonceptivo altamente eficaz durante el ensayo y durante los 6 meses posteriores a la última administración de azeliragon.
    Pacientes con participación concurrente en otro ensayo clínico de intervención o uso de otro agente en investigación dentro de los 14 días previos al inicio de azeliragon. Los pacientes que participan en ensayos clínicos no intervencionistas (p. ej., estudios de calidad de vida, estudios por imágenes, observacionales, de seguimiento, etc.) son elegibles, independientemente del momento de la participación.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the recommended dose for phase 2 (RP2D), defined as the highest dose in which 1 or fewer patients out of 6 treated present a DLT.
    Determinar la dosis recomendada para fase 2 (RP2D), definida como aquella dosis más alta en la que 1 o menos pacientes de 6 tratados presenta una TLD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days from initiation of dosing
    28 días desde el inicio del tratamiento
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints
    Locoregional failure rate (LFR)
    Disease-free survival (DFS)
    Overall Survival (OS)

    Secondary Security Variables
    Adverse events (AEs)
    Treatment-Related AEs (TREAs)
    Variables secundarias de eficacia
    Tasa de fracaso locorregional (TFL)
    Supervivencia libre de enfermedad (SLE)
    Supervivencia global (SG)

    Variables secundarias de seguridad
    Eventos adversos (EA)
    EA relacionados con el tratamiento (EART)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study period, approximately a median of 2 years
    A lo largo de todo el periodo de estudio, aproximadamente 2 años de media
    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 No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation, dose finding
    Escalado de dosis, búsqueda de dosis
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last patient last visit
    Ultima visita del ultimo paciente
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state18
    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)
    Best standard of care for the patient according to the physician criteria
    La mejor atención habitual para el paciente de acuerdo al criterio del médico
    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 Decision2023-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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