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    Summary
    EudraCT Number:2021-005569-42
    Sponsor's Protocol Code Number:B7461039
    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:2022-01-20
    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 number2021-005569-42
    A.3Full title of the trial
    LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
    PROTOCOLO DE CONTINUACIÓN DE LORLATINIB (PF-06463922): ESTUDIO ABIERTO DE CONTINUACIÓN DE UN ÚNICO GRUPO PARA PARTICIPANTES CON CÁNCER DE PULMÓN NO MICROCÍTICO (CPNM) POSITIVOS PARA ALK O PARA ROS1, CONTINUACIÓN DE ESTUDIOS CLÍNICOS DE LORLATINIB PATROCINADOS POR PFIZER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Original Protocol for Lorlatinib Continuation Study
    Estudio de continuación de lorlatinib
    A.4.1Sponsor's protocol code numberB7461039
    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 SponsorPfizer 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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10117
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 nameLorlatinib
    D.3.2Product code PF-06463922
    D.3.4Pharmaceutical form Film-coated 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 INNLorlatinib
    D.3.9.1CAS number 1454846-35-5
    D.3.9.2Current sponsor codePF-06463922
    D.3.9.3Other descriptive namePF-06463922
    D.3.9.4EV Substance CodeSUB181272
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
    CÁNCER DE PULMÓN NO MICROCÍTICO (CPNM) POSITIVOS PARA ALK O PARA
    ROS1, CONTINUACIÓN DE ESTUDIOS CLÍNICOS DE LORLATINIB PATROCINADOS
    POR PFIZER
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    cáncer de pulmón
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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 monitor the safety and tolerability of study intervention(s)
    Para supervisar la seguridad y tolerabilidad de lo(s) tratamiento(s) del estudio
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the following criteria apply:
    1. Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study. No ongoing NCI CTCAE Grade ≥3 or intolerable Grade 2 AEs considered to be related to lorlatinib treatment.
    2. Participants must agree to follow the reproductive criteria as outlined in Appendix 3 (Section 10.3.1 for males and Section 10.3.2 for females).
    3. Adequate organ function as defined by the following criteria:
    - Hepatic function: Serum AST and serum ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN if liver function abnormalities were due to underlying malignancy; total serum bilirubin ≤1.5 × ULN (except participants with documented Gilbert’s syndrome);
    - Bone marrow function: absolute neutrophil count ≥1000/μL, platelets ≥50,000/μL; hemoglobin ≥8.0 g/dL;
    - Renal function: Serum creatinine ≤2.0 × ULN.
    4. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
    5. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    Solo serán aptos para su inclusión en el estudio los participantes que cumplan la totalidad de los criterios siguientes:
    1.Cualquier participante que esté recibiendo el tratamiento del estudio y obtenga beneficio clínico (según lo determine el
    investigador principal) en un estudio original de lorlatinib patrocinado por Pfizer. Ausencia de AA en curso de grado ≥3 según los
    CTCAE del NCI ni AA intolerables de grado 2 considerados como relacionados con el tratamiento con lorlatinib.
    2. Los participantes deben aceptar seguir los criterios reproductivos tal y como se indica en el apéndice 3 (Sección 10.3.1 para hombres y Sección 10.3.2 para mujeres).
    3. Función orgánica adecuada definida por los siguientes criterios:
    - Función hepática: aspartato-aminotransferasa (AST) y alanina-aminotransferasa (ALT) séricas ≤2,5 × límite superior de la normalidad (LSN) o AST y ALT ≤5 × LSN si las anomalías de la función hepática se debieran a una neoplasia maligna subyacente; bilirrubina sérica total ≤1,5 × LSN (excepto los participantes con síndrome de Gilbert documentado).
    - Función de la médula ósea: recuento absoluto de neutrófilos ≥1000/μl, plaquetas ≥50 000/μl; hemoglobina ≥8,0 g/dl.
    - Disfunción renal: creatinina sérica ≤2,0 × LSN.
    4. Los participantes deben estar dispuestos y ser capaces de cumplir con todas las visitas programadas, el plan de tratamiento y otros procedimientos del estudio.
    5. Capacidad de otorgar el consentimiento informado firmado, tal y como se describe en el Apéndice 1, Sección 10.1.3, lo que comprende el cumplimiento de los requisitos y las restricciones indicados en el documento de consentimiento informado (DCI) y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1. Female participants who are pregnant or breastfeeding.
    2. Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
    Los participantes serán excluidos del estudio si cumplen alguno de los criterios siguientes:
    1. Participantes de sexo femenino embarazadas o en periodo de lactancia.
    2. Cualquier motivo médico que, en opinión del investigador o del promotor, impida al participante la inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - AEs leading to permanent discontinuation of lorlatinib
    - All SAEs
    - Acontecimientos adversos (AA) que provocaron la interrupción permanente de lorlatinib
    - Todos los acontecimientos adversos graves (AAG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    China
    France
    Italy
    Japan
    Poland
    Singapore
    Spain
    Taiwan
    United Kingdom
    United States
    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
    The end of study is defined as when the last participant has discontinued from lorlatinib and has completed the safety follow-up period or 5 years after First Participant Dosed of the continuation study (whichever is sooner).
    El final del estudio se define cuando el último participante ha discontinuado la toma de lorlatinib y ha completado el periodo de seguridad de seguimiento de 5 años tras el primer participante que recibió la administración del estudio de continuación (lo que ocurra antes).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 200
    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
    ninguno
    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 Decision2022-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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