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    Summary
    EudraCT Number:2020-005213-40
    Sponsor's Protocol Code Number:SPI-POZ-501
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-30
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005213-40
    A.3Full title of the trial
    An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients who have had Previous Exposure to Poziotinib
    Studio di estensione in aperto per consentire la prosecuzione del trattamento e/o il
    follow-up dei pazienti con esposizione precedente a poziotinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib
    Uno studio che consente la prosecuzione del trattamento e/o Follow-up dei pazienti che sono stati precedentemente esposti a Poziotinib
    A.3.2Name or abbreviated title of the trial where available
    SPI-POZ-501
    SPI-POZ-501
    A.4.1Sponsor's protocol code numberSPI-POZ-501
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03744715
    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 SponsorSPECTRUM PHARMACEUTICALS
    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 supportSpectrum Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpectrum Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSanjay Mourya
    B.5.3 Address:
    B.5.3.1Street Address157 Technology Drive
    B.5.3.2Town/ cityIrvine
    B.5.3.3Post code92618
    B.5.3.4CountryUnited States
    B.5.4Telephone number009497439242
    B.5.5Fax number009497886706
    B.5.6E-mailSanjay.mourya@sppirx.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 namePoziotinib Hydrochloride
    D.3.2Product code [HM781-36B]
    D.3.4Pharmaceutical form Modified-release 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 INNPoziotinib hydrochloride
    D.3.9.1CAS number 1429757-68-5
    D.3.9.2Current sponsor codeHM781-36B
    D.3.9.4EV Substance CodeSUB195315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 namePoziotinib Hydrochloride
    D.3.2Product code [HM781-36B]
    D.3.4Pharmaceutical form Modified-release 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 INNPoziotinib hydrochloride
    D.3.9.1CAS number 1429757-68-5
    D.3.9.2Current sponsor codeHM781-36B
    D.3.9.4EV Substance CodeSUB195315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation
    Carcinoma polmonare non a piccole cellule (NSCLC), localmente avanzato o metastatico, con mutazioni inserzionali a carico dell’esone 20 di EGFR o HER2
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer, Locally Advanced or Metastatic
    Carcinoma polmonare non a piccole cellule (NSCLC), localmente avanzato o metastatico
    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 10066490
    E.1.2Term Progression of non-small cell lung cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To continue to monitor patients who appear to derive clinical benefit from poziotinib
    Proseguire il monitoraggio dei pazienti che sembrano trarre beneficio clinico da poziotinib
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of poziotinib in patients
    2. To evaluate the safety of poziotinib in patients
    1. Verificare l’efficacia di poziotinib nei pazienti
    2. Verificare la sicurezza di poziotinib nei pazienti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has had previous exposure to poziotinib and is still receiving clinical benefit from treatment, as judged by the Investigator or treating physician.
    2. Patient must have completed the End-of-Treatment or End-of-Study Visit if enrolled in a previous (original) poziotinib study.
    3. Investigator or treating physician opinion indicates that extended therapy with poziotinib is clinically appropriate for the patient and the patient is suitable for this Study.
    4. Patient agrees to continue study treatment.
    5. Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements.
    6. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib.
    1. Paziente con una precedente esposizione a poziotinib e che sta ancora ricevendo beneficio clinico dal trattamento, come giudicato dallo Sperimentatore o dal medico curante.
    2. Il paziente deve aver completato la visita di fine trattamento o la visita di fine studio se arruolato in uno studio precedente (originale) su poziotinib.
    3. L’opinione dello Sperimentatore o del medico curante indica che la terapia estesa con poziotinib è clinicamente appropriata per il paziente e che questi è idoneo allo studio.
    4. Il paziente acconsente a proseguire il trattamento in studio.
    5. Il paziente deve fornire il Consenso informato per iscritto, deve essere in grado di rispettare il dosaggio e il calendario delle visite e deve soddisfare i requisiti per lo studio definiti dal protocollo.
    6. Il paziente è disposto a impiegare 2 forme di contraccezione, una delle quali deve essere rappresentata da un metodo a barriera, a partire dall’ingresso nello studio fino ad almeno 30 giorni dopo l’assunzione dell’ultima dose di poziotinib.
    E.4Principal exclusion criteria
    1. Patient has any ongoing adverse event that hasn't improved to Grade =1 and could impact the patient's tolerability to poziotinib.
    2. Patient has an active uncontrolled infection, bleeding disorder, underlying medical condition, or other serious illness that would impair the ability of the patient to receive poziotinib.
    3. Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the Investigator or treating physician.
    4. Patient's last dose of poziotinib was more than 28 days prior to Day 1 of the study.
    5. Patient is pregnant or breastfeeding.
    1. Il paziente ha un evento avverso in corso che non è migliorato fino al grado =1 e che potrebbe influenzare la tollerabilità del paziente a poziotinib.
    2. Il paziente presenta un’infezione attiva non controllata, disturbi emorragici, malattie di fondo o altre patologie gravi che potrebbero compromettere la capacità del paziente di assumere poziotinib.
    3. Il paziente presenta condizioni mediche o non mediche che potrebbero non essere adeguate al trattamento con poziotinib, come giudicato dallo Sperimentatore o dal medico curante.
    4. Il paziente ha assunto l’ultima dose di poziotinib più di 28 giorni prima del Giorno 1 dello studio.
    5. La paziente è in gravidanza o in allattamento.
    E.5 End points
    E.5.1Primary end point(s)
    To continue to monitor patients who appear to derive clinical benefit from poziotinib
    Proseguire il monitoraggio dei pazienti che sembrano trarre beneficio clinico da poziotinib
    E.5.1.1Timepoint(s) of evaluation of this end point
    The efficacy assessment is evaluated as per “Appendix1. Schedule of Assessments and Procedures” in the study protocol. The study endpoint will be evaluated when either the study is terminated or all patients have End-of-Study Visits whichever comes first.
    La valutazione dell'efficacia è valutata come riportato nell' Appendice1 "Schedule of Assessments and Procedures" del protocollo di studio. L'endpoint dello studio sarà valutato quando lo studio sarà terminato o quando tutti i pazienti avranno le visite di fine studio, a seconda di quale dei due eventi si verificherà per primo.
    E.5.2Secondary end point(s)
    1. To evaluate the efficacy of poziotinib in patients
    2. To evaluate the safety of poziotinib in patients
    1. Verificare l’efficacia di poziotinib nei pazienti
    2. Verificare la sicurezza di poziotinib nei pazienti
    E.5.2.1Timepoint(s) of evaluation of this end point
    The safety assessment is evaluated as per “Appendix1. Schedule of Assessments and Procedures” in the study protocol. The study endpoint will be evaluated when either the study is terminated or all patients have End-of-Study Visits whichever comes first.
    La valutazione della sicurezza è valutata come riportato nell' Appendice1 "Schedule of Assessments and Procedures" del protocollo di studio. L'endpoint dello studio sarà valutato quando lo studio sarà terminato o quando tutti i pazienti avranno le visite di fine studio, a seconda di quale dei due eventi si verificherà per primo.
    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 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) 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 No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    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
    Italy
    Netherlands
    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
    All patients who receive at least one dose of study treatment in this Extension Study will be followed for up to 35 (±5) days after their last dose of poziotinib or until all treatment-related AEs have resolved or returned to Baseline/Grade 1, whichever is longer, or until it is determined that the outcome will not change with further follow-up.
    Tutti i pazienti che ricevono almeno una dose di trattamento in questo studio di estensione saranno seguiti fino a 35 (±5) giorni dopo l'ultima dose di poziotinib o fino a quando tutti gli eventi avversi legati al trattamento sono stati risolti o sono tornati al livello base/grado 1, a seconda di quale sia il periodo più lungo, o fino a quando si stabilisce che l'esito non cambierà con un ulteriore follow-up.
    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 months4
    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: 40
    F.1.3Elderly (>=65 years) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 40
    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)
    Standard of Care
    Terapia Standard
    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 Decision2021-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-11
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