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    Summary
    EudraCT Number:2021-002352-36
    Sponsor's Protocol Code Number:BO41929
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-03-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-002352-36
    A.3Full title of the trial
    A PHASE II, OPEN-LABEL, SINGLE-ARM DECENTRALIZED HOME-BASED APPROACH STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALECTINIB IN LOCALLY ADVANCED OR METASTATIC ALK-POSITIVE SOLID TUMORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Alectinib in Locally Advanced or Metastatic ALK-Positive Solid Tumors
    A.3.2Name or abbreviated title of the trial where available
    Alpha T
    A.4.1Sponsor's protocol code numberBO41929
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04644315
    A.5.4Other Identifiers
    Name:IND Number:111723
    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 SponsorF. Hoffmann La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche, Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Yes
    D.2.1.1.1Trade name Alecensa
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmBH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAlectinib
    D.3.2Product code RO5424802
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAlectinib
    D.3.9.1CAS number 1256589-74-8
    D.3.9.2Current sponsor codeRO5424802/F03
    D.3.9.4EV Substance CodeSUB178557
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlectinib
    D.3.9.1CAS number 1256589-74-8
    D.3.9.2Current sponsor codeRO5424802/F16
    D.3.9.4EV Substance CodeSUB178557
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Anaplastic lymphoma kinase (ALK)-positive solid tumors
    E.1.1.1Medical condition in easily understood language
    Solid tumors are masses of abnormal tissue growth that originate in organs or soft tissues and do not include fluid areas and cysts
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084713
    E.1.2Term Tumor
    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 demonstrate a clinically relevant response to experimental treatment
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of alectinib in patients with ALK-positive solid tumors in the response evaluable population
    •To evaluate the safety of alectinib in all dosed patients
    •To characterize the alectinib pharmacokinetic (PK) profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age >= 18 years at time of signing Informed Consent Form
    •Histologically confirmed locally advanced or metastatic solid tumor excluding lung cancer
    •ALK-positive tumor per FMI NGS (NGS F1CDx, F1LCDx, or F1HEME) or per local accredited laboratory using validated NGS testing of tumor tissue or peripheral blood
    •Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
    •Other prior cancer therapies are allowed
    •Measurable disease at baseline, as assessed by investigator (by RECIST v1.1, or according to RANO criteria for patients with primary CNS tumors)
    •Life expectancy of at least 12 weeks in the opinion of the investigator
    •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
    •Adequate hematologic, hepatic, renal function
    •Patients with primary CNS tumors are eligible
    •Patients with CUP tumors are eligible
    •Patient with brain or leptomeningeal metastasis are allowed in the study if asymptomatic and if they meet the following criteria:
    -No neurological signs and clinically stable for at least 2 weeks without corticosteroid treatment for brain metastasis prior to first dose of alectinib
    -If previously treated with whole brain radiotherapy or gamma-knife radiosurgery, treatment must have been completed at least 2 weeks prior to first dose of alectinib
    •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
    •Willingness to comply with home-based approach and visits by mHCPs
    •Ability to swallow alectinib capsules intact (without chewing, crushing, or opening)
    •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of alectinib. Women must refrain from donating eggs during this same period.
    •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm during the treatment period and for least 90 days after the final dose of alectinib
    E.4Principal exclusion criteria
    •Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
    •Lung cancer
    •Patients with one of the following ALK point mutations: I1171X, G1202R, V1180L
    •Prior therapy with an ALK inhibitor
    •Liver disease characterized by any of the following:
    – Impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices
    – Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis
    •Known HIV infection
    •Patients with symptomatic bradycardia
    •Patients with symptomatic or unstable brain metastasis
    •Patients with primary CNS tumors are allowed
    •Malabsorption syndrome or any other condition that would interfere with enteral absorption
    •Incomplete recovery from any surgery prior to treatment
    •Any other malignancies within 5 years prior to enrollment, except any cured cancer that is considered to have no impact on PFS or OS for the current ALK-positive solid tumor
    •Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
    •History of hypersensitivity to alectinib or any of its excipients
    E.5 End points
    E.5.1Primary end point(s)
    1.Confirmed objective response rate (ORR), defined as the proportion of patients with a complete response [CR] or a PR >= 28 days after initial response in patients with solid tumors, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Up to 5 years
    E.5.2Secondary end point(s)
    1.Confirmed ORR, defined as the proportion of patients with a CR or PR >= 28 days after initial response by blinded independent center review (BICR) according to RECIST v1.1
    2.Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by both the investigator and by BICR according to RECIST v1.1
    3.Progression-free survival (PFS), defined as the time from first dose of alectinib treatment to disease progression or death from any cause, as determined by both the investigator and BICR according to RECIST v1
    4.CNS ORR, defined as objective tumor response rate (a CR or a PR) of CNS lesions in patients with measurable CNS metastases at baseline by BICR according to RECIST v1.1
    5.CNS DOR, defined as the time from the first observation of CNS response until the first observation of CNS progression or death from any cause by BICR according to RECIST v1.1
    6.Overall survival (OS), defined as the time from first dose of study drug to death from any cause
    7.Incidence and severity of adverse events, including serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
    8.Change from baseline in targeted vital signs
    9.Change from baseline in targeted clinical laboratory test results
    10.Plasma concentrations of alectinib and its metabolite(s) as applicable at specified time points
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7.Up to 5 years
    8-9.Baseline (Week 1) to 5 years
    10.Baseline, Week 4 and every 4 weeks thereafter during the treatment period
    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 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 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 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 EEA3
    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
    Denmark
    Sweden
    United Kingdom
    Spain
    Switzerland
    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 or last data point required for statistical analysis or safety follow up from last patient , which ever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years4
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 50
    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 Decision2022-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-17
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