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    The EU Clinical Trials Register currently displays   43692   clinical trials with a EudraCT protocol, of which   7246   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:2021-002566-40
    Sponsor's Protocol Code Number:20200491
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-20
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2021-002566-40
    A.3Full title of the trial
    A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 757 in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of AMG 757 in Patients with Small Cell Lung Cancer (SCLC)
    A.4.1Sponsor's protocol code number20200491
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Biofarmacêutica, Lda.
    B.5.2Functional name of contact pointMedical Information Department
    B.5.3 Address:
    B.5.3.1Street AddressEdifício Dª. Maria (Q60), Piso 2 A, Quinta da Fonte
    B.5.3.2Town/ cityPaço d'Arcos
    B.5.3.3Post code2770-229
    B.5.3.4CountryPortugal
    B.5.4Telephone number+35121422 06 06
    B.5.5Fax number+35121422 05 99
    B.5.6E-mailMedInfoPT@amgen.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 nameAMG 757
    D.3.2Product code AMG 757
    D.3.4Pharmaceutical form Powder 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 INNAMG 757
    D.3.9.3Other descriptive nameAMG 757
    D.3.9.4EV Substance CodeSUB189746
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Relapsed/Refractory Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Relapsed/Refractory Small Cell Lung Cancer
    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 10041070
    E.1.2Term Small cell lung cancer recurrent
    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
    Part 1 only
    •To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of AMG 757

    All part
    •Evaluate anti-tumor activity of AMG 757 as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
    E.2.2Secondary objectives of the trial
    •Evaluate anti-tumor activity of AMG 757 as determined by other measures per RECIST 1.1 by BICR
    •Evaluate anti-tumor activity of AMG 757 as assessed by ORR and other measures per RECIST 1.1 by investigator
    •Evaluate the safety and tolerability of AMG 757
    •Characterize the pharmacokinetics (PK) of AMG 757
    •Evaluate the immunogenicity of AMG 757
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent/assent prior to initiation of any study
    specific activities/procedures.
    102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
    103 Histologically or cytologically confirmed relapsed/refractory SCLC
    104 Subjects who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
    Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients to have failed PD-L1 inhibitor as part of their first line systemic treatment or not have access to.
    105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.
    106 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    107 Minimum life expectancy of 12 weeks.
    108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first
    dose of AMG 757.
    109 Subjects with treated brain metastases are eligible provided they meet the following criteria:
    - Definitive therapy was completed at least 2 weeks prior to the first dose of AMG 757.
    - There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
    - Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.
    110 Adequate organ function, defined as follows:
    hematological function:
    - absolute neutrophil count >= 1 x 10^9/L
    - platelet count >= 100 x 10^9/L
    - hemoglobin > 9 g/dL (90 g/L)
    coagulation function:
    - prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) <= 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.
    renal function:
    - estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2
    hepatic function:
    - aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 3 X ULN (or < 5 X ULN for subjects with liver involvement)
    - total bilirubin < 1.5 X ULN (or < 2 X ULN for subjects with liver metastases)
    pulmonary function:
    - no clinically significant pleural effusion
    - baseline oxygen saturation > 90% on room air
    cardiac function:
    - cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings
    E.4Principal exclusion criteria
    Disease Related
    201 Untreated or symptomatic brain metastases and leptomeningeal disease.
    202 Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
    203 Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
    204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 day) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
    Other Medical Conditions
    205 History of other malignancy within the past 2 years, with the following exceptions:
    - malignancy treated with curative intent and with no known active disease
    present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    - adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    - adequately treated cervical carcinoma in situ without evidence of disease.
    - adequately treated breast ductal carcinoma in situ without evidence of disease.
    - prostatic intraepithelial neoplasia without evidence of prostate cancer.
    - adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
    206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757 (Section 11.9).
    207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757.
    208 Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757.
    NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis or have any clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours.
    209 Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter).
    NOTE: A pleural catheter or dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
    210 History of hypophysitis or pituitary dysfunction.
    211 Exclusion of hepatitis infection based on the following results and/or criteria:
    - Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic
    hepatitis B or recent acute hepatitis B).
    - Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary.
    Detectable hepatitis B virus DNA suggests occult hepatitis B.
    - Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
    212 Major surgery within 28 days of first dose AMG 757.
    213 History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with medical monitor and meeting the following criterion: no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of AMG 757 (counted from day of positive test for asymptomatic subjects)
    Prior/Concomitant Therapy
    214 Subject received prior therapy with AMG 757.
    215 Prior anti-cancer therapy within 28 days prior to first dose of AMG 757.
    Exceptions:
    - Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade <=1.
    - Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757.
    216 Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757.
    217 Live and live-attenuated vaccines within 4 weeks prior to the start off AMG 757 treatment, during treatment, and until end of last study dose.

    Please refer to protocol for exclusion criteria 218 to 228.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 only
    •objective response (OR) (complete response [CR] and partial response [PR])
    •incidence of treatment-emergent adverse events (TEAEs)
    •serum concentrations of AMG 757

    All parts
    •OR (CR and PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis is planned when all subjects have been enrolled and have had the opportunity to have at least 6 months of follow up from the first post-baseline tumor assessment.

    The final analysis will occur when enrollment is complete and each subject completes the study, including long-term follow up.
    E.5.2Secondary end point(s)
    •duration of response (DOR)
    •disease control (DC)
    •duration of DC
    •progression-free survival (PFS)
    •DOR
    •overall survival (OS)
    •incidence of TEAEs
    •serum concentrations of AMG 757
    •incidence of anti-AMG 757 antibody formation
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis is planned when all subjects have been enrolled and have had the opportunity to have at least 6 months of follow up from the first post-baseline tumor assessment.

    The final analysis will occur when enrollment is complete and each subject completes the study, including long-term follow up.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    Japan
    Korea, Republic of
    Singapore
    Taiwan
    United States
    Switzerland
    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 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 160
    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 Decision2021-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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