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    Summary
    EudraCT Number:2019-004554-29
    Sponsor's Protocol Code Number:KRT-232-109
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-29
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-004554-29
    A.3Full title of the trial
    An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib
    A.4.1Sponsor's protocol code numberKRT-232-109
    A.5.4Other Identifiers
    Name:IND NumberNumber:147148
    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 SponsorKartos Therapeutics, 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 supportKartos Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKartos Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Operations- Josh Martino
    B.5.3 Address:
    B.5.3.1Street Address275 Shoreline Drive
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16505420136
    B.5.6E-mailjmartino@kartosthera.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 nameKRT-232
    D.3.2Product code KRT-232 (formerly AMG-232)
    D.3.4Pharmaceutical form 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 INNKRT-232
    D.3.9.2Current sponsor codeKRT-232
    D.3.9.3Other descriptive nameAMG 232
    D.3.9.4EV Substance CodeSUB123933
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKRT-232
    D.3.2Product code KRT-232 (formerly AMG-232)
    D.3.4Pharmaceutical form 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 INNKRT-232
    D.3.9.2Current sponsor codeKRT-232
    D.3.9.3Other descriptive nameAMG 232
    D.3.9.4EV Substance CodeSUB123933
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF)
    E.1.1.1Medical condition in easily understood language
    Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074689
    E.1.2Term Post polycythemia vera myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074690
    E.1.2Term Post essential thrombocythemia myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10074691
    E.1.2Term Post polycythaemia vera myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074692
    E.1.2Term Post essential thrombocythaemia myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077161
    E.1.2Term Primary myelofibrosis
    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
    For Phase 1:
    • To determine the KRT-232 RP2D in combination with ruxolitinib

    For Phase 2:
    • To determine the spleen volume reduction (SVR) at Week 24
    E.2.2Secondary objectives of the trial
    • To determine spleen response
    • To determine the change in Total Symptom Score (TSS) based on Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0)
    • To determine the duration of spleen response (DoR-spleen)
    • To determine spleen size reduction as measured by palpation
    • To determine red blood cell (RBC) transfusion usage
    • To determine the clinical response rate: complete response (CR) and partial response (PR)
    • To determine the overall survival (OS) rate
    • To determine progression-free survival (PFS)
    • To determine the leukemia-free survival rate
    • To determine the safety and tolerability of KRT-232
    • To monitor the PK of KRT-232, KRT-232 glucuronide and ruxolitinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults >18 years of age capable of providing informed consent.
    2. Confirmed diagnosis of PMF, post–PV-MF, or post–ET-MF, as assessed by treating physician according to the World Health Organization (WHO) criteria.
    3. Treatment with ruxolitinib for ≥ 18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to Sponsor approval of the enrollment form.
    4. Spleen ≥ 5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT
    5. Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0
    6. An MRI or CT scan for spleen volume must be performed no more than 14 days prior to the first dose of KRT-232.
    7. ECOG performance status of 0 to 2.
    8. Adequate hematological, hepatic, and renal organ function (as per protocol definition and within 28 days prior to the first dose of KRT-232).
    9. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use an effective contraception method during the study. A woman is considered of childbearing potential (ie, fertile, following menarche and until becoming post menopausal) unless permanently sterile (refer to Appendix 13 for additional details). In addition, after the last dose of study drug, female subjects must continue to use contraception for 1 month and 1 week and male subjects must continue to use contraception for 3 months and 1 week.
    E.4Principal exclusion criteria
    1. Patients who are positive for TP53 mutations.
    2. Documented disease progression or clinical deterioration any time while on ruxolitinib treatment.
    3. Patients who have had a documented spleen response to ruxolitinib.
    4. Participation in another interventional clinical trial within the past 4 weeks of the first dose of KRT-232 (participation in observational studies is permitted).
    5. Other JAK inhibitors, except for ruxolitinib treatment; other recent/concurrent treatment such as a major surgery, chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or investigational therapy within 4 weeks or approximately 5 half-lives before the first dose of KRT-232,
    whichever is shorter. Hydroxyurea is permitted up until the day prior to study Day 1 of study treatment with KRT-232.
    6. Prior splenectomy.
    7. Splenic irradiation within 3 months prior to the first dose of KRT-232.
    8. Prior allogeneic stem-cell transplantation or eligible for allogeneic stem cell transplantation
    9. Prior MDM2 inhibitor therapy or p53-directed therapy
    10. Women who are pregnant or breastfeeding
    11. History of major organ transplant
    12. Subjects positive for HIV-1; subjects positive for Hepatitis B DNA if either HbsAg or Hepatitis B core antibody is positive; subjects positive for viral HCV RNA if HCV antibody is positive.
    13. Active serious viral, mycobacterial, parasitic, fungal, and bacterial infections, including acute hepatitis A, herpes zoster, and progressive multifocal leukoencephalopathy (PML). Active
    serious infections must be resolved before screening/enrollment. Subjects with acute infections requiring systemic antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
    14. Patients with uncontrolled intercurrent illness including, but not limited to; clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; unstable angina pectoris; ventricular arrhythmia; or patients with psychiatric illness/social situations that would limit compliance with study requirements; or patients who have been committed to an institution by judicial or administrative authority.
    15. Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated nonmetastatic prostate cancer with normal prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma.
    16. Grade 2 or higher QTc prolongation (>480 milliseconds per NCI-CTCAE criteria, version 5.0).
    17. Active or chronic bleeding within 4 weeks prior to the first dose of KRT-232.
    18. Patients who have been committed to an institution by judicial or
    administrative authority.
    19. Known hypersensitivity or contraindication to any of the study drugs, required prophylaxes or their excipients

    E.5 End points
    E.5.1Primary end point(s)
    For Phase 1:
    Dose-limiting toxicity (DLTs) will be used to establish the maximum tolerated dose (MTD) of KRT-232 in combination with ruxolitinib. The SRC will determine the recommended phase 2 dose (RP2D) based on safety and efficacy data of the combination of KRT-232 and ruxolitinib.

    For Phase 2:
    The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)
    E.5.1.1Timepoint(s) of evaluation of this end point
    For Phase 1:
    Dose-limiting toxicity (DLT) evaluation period is the first cycle (i.e., the first 28 days). All AEs should be considered for DLTs unless reported as unrelated to the study drugs. Specific DLT criteria for nonhematologic toxicity, neutropenia, and thrombocytopenia can be referred from Clinical Protocol.

    For Phase 2:
    Week 24
    E.5.2Secondary end point(s)
    - The proportion of subjects achieving ≥ 35% SVR at any time point from Baseline while on study, as assessed by MRI (or by CT scan for applicable subjects).
    - The percentage change in TSS as measured by the MFSAF v4.0 at any time point from Baseline while on study.
    - Duration of a ≥ 35% reduction in SVR from Baseline as measured by MRI (or by CT scan for applicable subjects).
    - Reduction in spleen size from Baseline to each visit at which spleen is palpated, including the proportion of subjects who have a ≥ 50% decrease in spleen size
    - Red blood cell (RBC) transfusion usage:
    • Rate of RBC transfusion usage (average number of RBC units per patient-month)
    • Rate of change from RBC transfusion dependent to transfusion independent
    - The proportion of subjects with CR and PR at any time point, from Baseline while on study, defined according to International Working Group-Myeloproliferative Neoplasms Research and Treatment(IWG-MRT) and modified European Leukemia Net (ELN) criteria
    - OS is defined as the interval from randomization to death from any cause
    - PFS is the interval from Cycle 1 Day 1 to:
    • Disease progression (≥ 25% increase in spleen volume) or
    • Leukemic transformation (bone marrow blasts ≥20% or peripheral blood blasts ≥ 20% associated with an absolute blast count of at least 1 x 109/L that lasts for at least 2 weeks) or
    • Death from any cause
    - Leukemia-free survival is defined as the interval from Cycle 1 Day 1 to the date of first documented transformation to leukemia (bone marrow blasts ≥20% or peripheral blood blasts ≥20% associated
    with an absolute blast count of at least 1 x 109/L that lasts for at least 2 weeks).
    - Analyses of the safety endpoints will include the following measurements or assessments: physical examinations, laboratory tests, adverse events (AEs), serious AEs (SAEs), electrocardiograms (ECGs), and vital signs
    - KRT-232, acyl glucuronide metabolite (M1) and ruxolitinib PK parameters will be determined, including but not limited to:
    • Maximum observed concentration (Cmax)
    • Minimum observed concentration (Cmin)
    • Area under the plasma concentration-time curve (AUC)
    • Time of maximum plasma concentration

    E.5.2.1Timepoint(s) of evaluation of this end point
    Bone marrow aspirate and biopsy: At Screening visit and at Week 24.
    Palpation of Spleen Size: Performed at Screening and at each physical exam till end of treatment period
    MRI (or CT) of abdomen and Volumetric Measurement of Spleen: Week 12, Week 24, and every 12 weeks, and anytime splenic progression is suspected (this may be at an unscheduled imaging visit)
    Response assessment per IWG-MRT: At Week 24, and every 24 weeks
    PRO MFSAF TSS v4.0 Questionnaire: Daily until End of Treatment
    Transfusion dependence: At Screening and on Day 1 of every cycle
    Hematology: Cycle 1, 2, and 3 (Days 1, 8, 15, 22); Cycle 4 and beyond on Day 1 of each cycle
    AEs: Every visit
    Biomarkers: Subjects will have a blood sample collected and stored at the time points indicated in Table-3 of protocol.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    To determine MTD of KRT-232 in combination with ruxolitinib in a 3+3 dose-escalation design
    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 Yes
    E.8.1.7.1Other trial design description
    Safety and Efficacy of KRT-232 with Ruxolitinib in Patients with PMF, Post–PV-MF, Post-ET-MF
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Australia
    Bulgaria
    France
    Germany
    Hungary
    Israel
    Italy
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 study will be considered complete 2 years after the last subject is enrolled, at which time subjects who remain on study treatment will be evaluated for eligibility to enroll in a rollover study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 36
    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 Decision2020-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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