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    Summary
    EudraCT Number:2017-004836-13
    Sponsor's Protocol Code Number:BLU-285-2202
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-03
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-004836-13
    A.3Full title of the trial
    An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Mastocytosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Avapritinib in Patients with Advanced Systemic Mastocytosis
    A.3.2Name or abbreviated title of the trial where available
    PATHFINDER
    A.4.1Sponsor's protocol code numberBLU-285-2202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03580655
    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 SponsorBlueprint Medicines Corporation
    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 supportBlueprint Medicines Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health, LLC
    B.5.2Functional name of contact pointProject Director, Global Oncology
    B.5.3 Address:
    B.5.3.1Street Address1030 Sync Street
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1512904 4317
    B.5.6E-mailsara.hoffman@syneoshealth.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2074
    D.3 Description of the IMP
    D.3.1Product nameAvapritinib
    D.3.2Product code BLU-285, C-366, C366, 70C366, X720776, BLU112317
    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 INNAvapritinib
    D.3.9.2Current sponsor codeBLU-285
    D.3.9.4EV Substance CodeSUB178877
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2074
    D.3 Description of the IMP
    D.3.1Product nameAvapritinib
    D.3.2Product code BLU-285, C-366, C366, 70C366, X720776, BLU112317
    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 INNAvapritinib
    D.3.9.2Current sponsor codeBLU-285
    D.3.9.4EV Substance CodeSUB178877
    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
    Advanced Systemic Mastocytosis (AdvSM)
    E.1.1.1Medical condition in easily understood language
    Mastocytosis
    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 LLT
    E.1.2Classification code 10056453
    E.1.2Term Aggressive systemic mastocytosis
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine ORR of CR/CR with partial recovery of peripheral blood counts (CRh) + PR + CI based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib.
    E.2.2Secondary objectives of the trial
    Key secondary objective: assess mean change from baseline in AdvSM-Symptom Assessment Form (AdvSM-SAF) Total Symptom Score (TSS).
    Additional secondary objectives:
    -Determine time-to-event outcomes including time-to-response (TTR), duration of response (DOR), PFS and OS.
    -Assess changes in the individual measures of mast cell (MC) burden:
    o Bone marrow (BM) MCs
    o Serum tryptase
    o KIT mutation burden (eg, D816V) in peripheral blood
    o Liver and spleen volume by imaging
    -Determine CR/CRh + PR and clinical benefit (CR/CRh + PR + CI + Stable Disease [SD]) based on modified IWG-MRT-ECNM criteria.
    -Assess additional PROs using the AdvSM-SAF, including change from baseline in:
    o Symptom domain scores
    o Individual symptom scores
    -Assess changes in QoL measures, including the PGIS and EORTC QLQ-C30
    -Assess the safety of avapritinib by AEs, vital signs, ECGs, and laboratory tests
    -Assess the PK of avapritinib.
    -Correlate avapritinib exposure with safety and efficacy endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who are ≥ 18 years of age.
    2. Patients must have 1 of the following diagnoses as confirmed by World Health Organization (WHO) diagnostic criteria. Before enrollment, the SSC must confirm the diagnosis of AdvSM (based on Central Pathology Laboratory assessment of BM).
    • ASM.
    • SM-AHN. The AHN must be myeloid, with additional criteria defined in the protocol.
    • MCL.
    3. Patients with SM-AHN should have received prior treatment for the AHN component of disease if, in the opinion of the Investigator, such therapy was appropriate.
    4. Patient must have a BM biopsy available to be shipped to the Central Pathology Laboratory ≥ 21 days before initiation of study treatment (C1D1).
    5. Patient must have at least 1 measurable C-finding per modified IWG-MRT-ECNM, attributed to SM and evaluable for response assessment unless diagnosis is MCL, which does not require a C-finding. Laboratory abnormality C-findings should not be assessed until the required time period from last cytoreductive therapy has been met.
    6. Patient must have a serum tryptase ≥ 20 ng/mL.
    7. Patients with cytoreductive therapy within the preceding 12 weeks must have discontinued therapy due to disease progression, refractory disease, lack of efficacy, or intolerance.
    8. Patient must have symptom management optimized with nonantineoplastic therapies (ie, BSC; eg, H1 and H2 blockers). Dose must be stable for ≥ 14 days before C1D-8.
    9. If the patient is receiving corticosteroids, the dose must be ≤ 20 mg/d prednisone or equivalent and dose must be stable for ≥ 14 days before C1D-8.
    10. Patient has an Eastern Cooperative Oncology Group Performance Status of 0 to 3.
    11. Patient must give written informed consent.
    E.4Principal exclusion criteria
    1. Patient has received prior treatment with avapritinib.
    2. Patient has received any cytoreductive therapy (including midostaurin and other TKIs, hydroxyurea, azacitidine) or an investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon and any antibody therapy (eg, brentuximab vedotin) less than 28 days before obtaining screening BM biopsy for this study.
    3. Patient has received prior radiotherapy within 14 days before the screening BM biopsy, unless given to palliate specific sites of disease (eg, bone lesion).
    4. Patient received any hematopoietic growth factor within 14 days of screening BM biopsy.
    5. Patient requires therapy with a concomitant medication that is a strong inhibitor, strong inducer, or moderate inducer of CYP3A4.
    6. Patient has had a major surgical procedure within 14 days of the first dose of study drug. Surgical procedures such as central venous catheter placement, BM biopsy, and feeding tube placement are considered minor surgical procedures.
    7. Patient is a candidate for allogeneic hematopoietic stem cell transplantation for treatment of SM, in the opinion of the Investigator.
    8. Patient has eosinophilia and known positivity for the FIP1L1-PGDFRA fusion, unless the patient has demonstrated relapse or PD on prior imatinib therapy. Patients with eosinophilia (> 1.5 × 10^9/L), who do not have a detectable KIT D816 mutation, should be tested for a PDGFRA fusion mutation by fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR).
    9. Patient has history of another primary malignancy that has been diagnosed or required therapy within 3 years before the first dose of study drug. The following are exempt from the 3-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.
    10. Patient meets any of the following laboratory criteria:
    o AST or ALT > 3.0 × ULN; no restriction if due to suspected liver infiltration by MCs.
    o Bilirubin > 1.5 × ULN; no restriction if due to suspected liver infiltration by MCs or Gilbert’s disease.
    o Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 or creatinine clearance calculated by Cockcroft-Gault equation < 40 mL/min.
    11. Patient has a QT interval corrected using Fridericia’s formula (QTcF) > 450 msec.
    12. Patient has a history of a seizure disorder (eg, epilepsy) or requirement for antiseizure medication.
    13. Patient has a history of a cerebrovascular accident or transient ischemic attacks within 1 year before the first dose of study drug.
    14. Patient has a known risk or recent history (within the preceding 1 year) of intracranial bleeding (eg, brain aneurysm).
    15. Patient has a primary brain malignancy or metastases to the brain.
    16. Patient has clinically significant, uncontrolled cardiovascular disease, including Grade III or IV congestive heart failure according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months; clinically significant, uncontrolled arrhythmias; or uncontrolled hypertension.
    17. Patient is unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
    18. Female patients who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during the study drug administration period and for at least 30 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during the study drug administration period and for at least 90 days after the last dose of study drug.
    19. Female patients who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy obtained within 15 days before the first dose of study drug. Women with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written approval of the Sponsor after pregnancy has been excluded. Women of nonchildbearing potential (ie, women who are postmenopausal or have undergone hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) do not require a serum β-hCG pregnancy test.
    20. Women who are breast feeding.
    21. Patient has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the opinion of the Investigator, could affect the safety of the patient, alter the absorption, distribution, metabolism, or excretion of the study drug, or impair the assessment of study results.
    E.5 End points
    E.5.1Primary end point(s)
    ORR (CR/CRh + PR + CI) based on modified IWG-MRT-ECNM criteria, confirmed 12 weeks after initial response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At C1D15, C2D1, C3D1, C7D1 and C11D1 and then every 6 cycles. Also performed 12 weeks (± 4 weeks) after documentation of CR or PR to confirm response and 4 weeks after SM and/or AHN PD or clinical progression to confirm PD. Performed at EOT if patient discontinues for reasons other than PD or initiation of alternative cytoreductive therapy.
    E.5.2Secondary end point(s)
    • Mean change from baseline in AdvSM-SAF TSS.

    Additional secondary endpoints:
    • Time-to-event outcomes including TTR, DOR, PFS, and OS.
    • Changes in BM MCs, serum tryptase, KIT mutation burden (eg, D816V) in PB, and liver and spleen volume by imaging.
    • CR/CRh + PR and clinical benefit (CR/CRh + PR + CI + SD) based on modified IWG-MRT-ECNM criteria.
    • Mean change from baseline in AdvSM-SAF domain and individual symptom scores.
    • Changes in PGIS and EORTC QLQ-C30 (global health status, functional scales, and symptom scales/items) score.
    • Safety of avapritinib, as assessed by AEs, changes in vital signs, ECGs, and laboratory testing.
    • PK of avapritinib.
    • Correlations between avapritinib exposure and safety and efficacy endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • AdvSM-SAF: daily from C1D7 to C17 or until patient discontinuation
    • OS: until death or loss to F/U
    • BM biopsy/aspirate: screening, C3D1, C7D1, C11D1, every 6 cycles, EOT, PD F/U
    • Serum tryptase, liver/spleen imaging: screening, C1D15, C2D1, C3D1, C7D1, C11D1, every 6 cycles, EOT, PD F/U
    • KIT D816V mutant allele burden: screening, C1D1, C1D15, C2D1, C3D1, C7D1, C11D1, every 6 cycles, EOT, PD F/U
    • Response: C1D15, C2D1, C3D1, C7D1, C11D1, every 6 cycles, EOT, PD F/U
    • PGIS, EORTC QLQ-C30: each visit through C17, EOT
    • AE: from C1D1 to Safety F/U
    • Vital signs & ECG: each visit through EOT
    • Lab: screening, each visit from C1D15 to EOT, PD F/U
    • PK: C1D1, C2D1, C3D1, C5D1 predose and any 1 time point between 1 and 8 hrs postdose, C1D15 predose, 1, 4 and 6 to 8 hrs postdose
    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 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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Denmark
    Germany
    Italy
    Netherlands
    Norway
    Poland
    Spain
    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 the study is defined as the time that the last patient completes his/her last visit (LPLV), including assessments performed as part of follow-up for OS, if the patient enters the OS follow-up period of the study.
    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 months10
    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
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    Normal standard of care.
    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 Decision2019-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
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