Primary Myelofibrosis (PMF)Phase 2/3BOREASNCT03662126
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
A Phase 2/3 study testing KRT-232 and Best Available Therapy (BAT) in people with Primary Myelofibrosis (PMF) and Post-Polycythemia Vera MF (Post-PV-MF), run by Kartos Therapeutics, Inc. at 191 sites in 28 countries.
Trial summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Post-Essential Thrombocythemia MF (Post-ET-MF)
- What is being tested?
- KRT-232 and Best Available Therapy (BAT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 191 sitesin 28 countries
- Study dates
- 15 Jan 2019to 31 Dec 2025
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
- High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
- Failure of prior treatment with JAK inhibitor
- ECOG ≤ 2
Who cannot join
- Prior splenectomy
- Splenic irradiation within 3 months prior to randomization
- History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
- History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
- Prior MDM2 inhibitor therapy or p53-directed therapy
- Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
- History of major organ transplant
- Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
Trial locations and contacts
191 sites in 28 countries.
191 sites in 28 countries
United States19 sites, 9 recruiting
- Active, not recruiting
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35294
- Withdrawn
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Withdrawn
University Cancer Institute
Boynton Beach, Florida, 33426
- Recruiting
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
- Recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
- Completed
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
- Completed
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
- Withdrawn
New York Presbyterian/Weill Cornell Medical Center
New York, New York, 10021
- Recruiting
Mt. Sinai
New York, New York, 10029
- Completed
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Active, not recruiting
Stanford Cancer Center - Palo Alto
Stanford, California, 94305
- Completed
Innovative Clinical Research Institute
Whittier, California, 90603
Italy15 sites, 15 recruiting
- Recruiting
PO Civile SS.Antonio e Biagio
Alessandria, 15121
- Recruiting
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
Ancona, 60123
- Recruiting
A.O.di Bologna Policl.S.Orsola
Bologna, 41038
- Recruiting
AO Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliero Universitaria Policlinico - Vittorio Emanuele
Catania, 95123
- Recruiting
AOU Careggi
Florence, 50141
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola
- Recruiting
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milan, 20122
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
A.O. San Gerardo di Monza - L'Ospedale San Gerardo di Monza e l'Università di Milano
Monza, Lombardy, 20900
- Recruiting
AOU Maggiore della Carità
Novara, 28100
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord - Pesaro
Pesaro, 61121
- Recruiting
Arcispedale S. Maria Nuova, AO di Reggio Emilia
Reggio Emilia, 42123
- Recruiting
Policlinico Universitario Agostino Gemelli
Roma, 00168
- Recruiting
A.O. Citta della Salute e della Scienza di Torino
Torino, 10126
Brazil12 sites, 12 recruiting
- Recruiting
UNICAMP - Universidade Estadual de Campinas Hemocentro
Campinas, São Paulo, 13083
- Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná, 81520
- Recruiting
Centro de oncologia Leonardo da Vinci
Fortaleza, Ceará, 60140-025
- Recruiting
Hospital das Clínicas UFG
Goiânia, 74605
- Recruiting
Fundacao Doutor Amaral Carvalho
Jaú, 17210-120
- Recruiting
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
Porto Alegre, 90035-903
- Recruiting
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
Porto Alegre, 90880-480
- Recruiting
Instituto de Ensino e Pesquisa São Lucas
São Paulo, 01236-030
- Recruiting
Hospital A C Camargo - Fundacao Antonio Prudente
São Paulo, 01509-900
- Recruiting
Instituto D'or de Pesquisa e Ensino
São Paulo, 04502-001
- Recruiting
Hospital das Clínicas da Universidade de São Paulo
São Paulo, 05403-000
- Recruiting
Instituto COI São Paulo
São Paulo, 1321001
Germany12 sites, 10 recruiting
- Active, not recruiting
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
- Recruiting
Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle
Dresden, Saxony, 01307
- Recruiting
Technische Universität Dresden
Dresden, Saxony, 01307
- Recruiting
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
- Recruiting
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120
- Recruiting
UKE - Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
- Active, not recruiting
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz
- Recruiting
Klinikum Rechts der Isar der Technischen Universität München Apotheke
München, Bavaria, 81675
- Recruiting
Stauferklinikum Schwäbisch Gmünd
Mutlangen, 73557
- Recruiting
Praxis für Hämatologie und Onkologie
Saarbrücken, 66113
Spain12 sites, 11 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
- Recruiting
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
- Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041
- Recruiting
Hospital San Pedro de Alcantara
Cáceres, 1003
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Las Palmas, 35010
- Active, not recruiting
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, 07120
- Recruiting
Complejo Hospitalario de Navarra - H. de Navarra, Hematología C/ de Irunlarrea, 3, Pamplona
Pamplona, 31008
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Doctor Peset
Valencia, 46017
- Recruiting
H. Quirón Zaragoza
Zaragoza, 50012
France11 sites, 9 recruiting
- Recruiting
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Hématologie Clinique
Amiens, 80054
- Recruiting
Center Hospitalier Universitaire d'Angers
Angers, 49933 Cedex 09
- Recruiting
C.H de la Côte Basque - Serviv
Bayonne, 64100
- Recruiting
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, 29609
- Active, not recruiting
Centre Hospitalier Universitaire of Caen Normandie - Côte de Nacre
Caen, 14000
- Recruiting
Centre Hospitalier Le Mans
Le Mans
- Active, not recruiting
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029 Cedex 9
- Recruiting
Hôpital Saint-Louis
Paris, 75010
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers
- Recruiting
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, 31059
- Recruiting
Hopital Paul Brousse - Aphp Hôpitaux Universitaires Paris Su
Villejuif, 94800
Israel11 sites, 11 recruiting
- Recruiting
Ha'Emek Medical Center
Afula, 1834111
- Recruiting
Assuta Ashdod University Hospital
Ashdod
- Recruiting
Rambam Medical Centre
Haifa, 31096
- Recruiting
Carmel MC
Haifa
- Recruiting
Hadassah Medical Organisation
Jerusalem, 91120
- Recruiting
Hematology Institute
Kfar Saba, 44281
- Recruiting
Western Galilee Hospital - Nahariya
Nahariya, 22100
- Recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 49100
- Recruiting
Tel Aviv Sourasky Medical Center - Oncology
Tel Aviv, 6423906
- Recruiting
Assuta MC
Tel Aviv, 64239
- Recruiting
Assaf Harofeh Medical Center - Hematology
Ẕerifin, 7030000
Romania10 sites, 10 recruiting
- Recruiting
Cen Med de Diagn si Trat Amb NEOMED
Brasov, 500283
- Recruiting
Spitalul Clinic Colentina
Bucharest, 020125
- Recruiting
Spitalul Clinic Coltea
Bucharest, 030171
- Recruiting
Medicover
Bucharest, 060201
- Recruiting
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, 400015
- Recruiting
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143
- Recruiting
Institutul Regional de Oncologie Iasi
Iași, 700483
- Recruiting
Spitalul Clinic Judetean de Urgenta Tg Mures
Târgu Mureş, 540136
- Recruiting
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300079
- Recruiting
Oncomed
Timișoara, 300329
Poland9 sites, 6 recruiting
- Active, not recruiting
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Podkarpackie Voivodeship, 36-200
- Recruiting
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz, 86-168
- Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Chorzów, Silesian Voivodeship, 41-500
- Withdrawn
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, 20-081
- Recruiting
SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii
Olsztyn
- Recruiting
Szpital Wojewódzki w Opolu
Opole, 45-061
- Withdrawn
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością Medic-R sp. k.
Poznan, 60-848
- Recruiting
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, 76-200
- Recruiting
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
Wroclaw, Lower Silesian Voivodeship, 53-439
South Korea8 sites, 8 recruiting
- Recruiting
Inje University Busan Paik Hospital
Busan, 47392
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
- Recruiting
Yeungnam University Medical Center
Daegu, 42415
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, Seongnam-si
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
Turkey (Türkiye)8 sites, 8 recruiting
- Recruiting
Sakarya Research and Training Hospital
Adapazarı, 54100
- Recruiting
Ankara University Faculty of Medicine
Ankara, 06500
- Recruiting
Gazi University Medical Faculty
Ankara, 06500
- Recruiting
Pamukkale University
Denizli, 20160
- Recruiting
Gaziantep University Faculty of Medicine
Gaziantep, 27100
- Recruiting
Inonu University Turgut Ozal Medical Center
Malatya, 44280
- Recruiting
Mersin University Medical Faculty
Mersin, 33110
- Recruiting
Ondokuz Mayis University Medical Faculty - Hematology
Samsun, 55280
Bulgaria7 sites, 6 recruiting
- Recruiting
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven
Pleven
- Recruiting
University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv
Plovdiv
- Recruiting
Military Medical Academy, Multiprofile for active treatment, Sofia
Sofia, 1606
- Recruiting
Acibadem City Clinic Tokuda Hospital, Sofia
Sofia
- Recruiting
Specialized Hospital for Active Therapy of Hematological Disorders
Sofia
- Withdrawn
University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia
Sofia
- Recruiting
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia
Sofia
Hungary7 sites, 4 recruiting
- Withdrawn
Semmelweis Egyetem
Budapest, 1083
- Recruiting
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
Budapest
- Completed
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
Debrecen, 4032
- Withdrawn
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, 7400
- Recruiting
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
- Recruiting
Szegedi Tudományegyetem
Szeged, 6725
- Recruiting
Markusovszky Egyetemi Oktatókórház
Szombathely, Vas County, H-9700
Australia6 sites, 6 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
The Alfred Hospital
Melbourne
- Recruiting
Fiona Stanley Hosital
Murdoch, Western Australia, 6150
- Recruiting
South Eastern Private Hospital
Noble Park, 3174
- Recruiting
Icon Cancer Center
South Brisbane
Portugal5 sites, 5 recruiting
- Recruiting
H. Infante Dom Pedro. Centro Hospitalar do Baixo Vouga
Aveiro, 3814-501
- Recruiting
Hospital de Braga
Braga, 4710-243
- Recruiting
Instituto Português de Oncologia de Coimbra
Coimbra, 3000-075
- Recruiting
Champalimaud Cancer Center
Lisbon, 1400-038
- Recruiting
H. São Francisco Xavier-Centro Hospitalar Lisboa Ocidental
Lisbon, 1495-005
Thailand5 sites, 5 recruiting
- Recruiting
Ramathibodi Hospital - Mahidol University - Hematology
Bangkok, 10400
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Thammasat University Hospital
Khlong Luang, 12120
- Recruiting
Srinagarind Hospital (KhonKaen University)
Khon Kaen, 40002
- Recruiting
Songklanagarind Hospital
Songkhla, 90110
Argentina4 sites, 4 recruiting
- Recruiting
Instituto Medico Alexander Fleming
Buenos Aires
- Recruiting
Centro Medico San Luis
CABA, 1425
- Recruiting
Hospital Privado - Centro Medico de Cordoba - Oncology
Córdoba, X5016KEH
- Recruiting
Sanatorio de la Mujer
Rosario, Santa Fe Province, S2000ORE
Mexico4 sites, 4 recruiting
- Recruiting
Universidad Autonoma de Nuevo Leon (UANL) - Hospital Universitario "Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
- Recruiting
Instituto Mexicano del Seguro Social
Monterrey, 64180
- Recruiting
Oaxaca Site Management Organization OSMO
Oaxaca City, 6800
- Recruiting
Sociedad de Metabolismo y Corazón S.C. - Oncology
Veracruz, 91910
Taiwan4 sites, 4 recruiting
- Recruiting
Chang Gung Medical Foundation - ChiaYi Chang Gung Memorial Hospital - Chiayi Branch
Chiayi City
- Recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
National Taiwan University Hospital
Taipei City, Taipei, 100
United Kingdom4 sites
- Active, not recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham
- Active, not recruiting
NHS Greater Glasgow and Clyde
Glasgow
- Active, not recruiting
Guy's and Saint Thomas' NHS Foundation Trust
London, SE1 9RT
- Active, not recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
Croatia3 sites, 3 recruiting
- Recruiting
General Hospital Sibenik
Šibenik, 22000
- Recruiting
Clinical Hospital Centre Osijek
Zagreb, 10000
- Recruiting
KB Sestre Milosrdnice
Zagreb, 10000
Czechia3 sites, 2 recruiting
- Recruiting
FN Hradec Kralove
Králová, 500 05
- Recruiting
Vseonecma fakultni nemocrince V Praze
New Town
- Withdrawn
Fakultní Nemocnice Olomouc
Olomouc, 779 00
Greece3 sites, 3 recruiting
- Recruiting
University General Hospital of Ioannina
Ioannina, Ioannina, 45500
- Recruiting
University Campus of Patras - Hematology
Pátrai, 26504
- Recruiting
AHEPA General Hospital of Thessaloniki
Thessaloniki, 54636
Russia3 sites
- Withdrawn
Clinical oncological dispensary
Omsk, 644013
- Withdrawn
Saint-Petersburg SMU I.P.Pavlov
Saint Petersburg, 197089
- Withdrawn
Oncologic dispensary of Komi Republic
Syktyvkar, 167904
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, 150001
- Recruiting
Prince of Wales Hospital - Medicine
Shatin
Philippines2 sites, 2 recruiting
- Recruiting
Perpetual Succour Hospital - Hemat/Transfusion Med
Cebu City, 6000
- Recruiting
University of the Philippines - Philippine General Hospital
Manila, 1000
Canada1 site
- Active, not recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, LT-50161
About this study
Official title: A Phase 2/3 Randomized, Controlled, Open-Label Study of KRT 232 in Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (Post-PV-MF), Or Post Essential Thrombocythemia MF (Post-ET-MF) Who Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.
- Conditions
- Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Post-Essential Thrombocythemia MF (Post-ET-MF)
- Being tested
- KRT-232, Best Available Therapy (BAT)
- Keywords
- navtemadlin
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRT-232Drug
KRT-232, administered by mouth
Best Available Therapy (BAT)Drug
Best available therapy options include:
- hydroxyurea
- chemotherapy or
- supportive care (including but not limited to corticosteroids and androgens; JAK inhibitors not allowed).
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1 | Experimental | KRT-232 120 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) Receives: Drug: KRT-232 |
| Part A Cohort 2 | Experimental | KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles) Receives: Drug: KRT-232 |
| Part A Cohort 3 | Experimental | KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles) Receives: Drug: KRT-232 |
| Part A Cohort 4b | Experimental | KRT-232 240 mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles) Receives: Drug: KRT-232 |
| Part B Arm 1 KRT-232 | Experimental | KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles) Receives: Drug: KRT-232 |
| Part B Arm 2 Best Available Therapy | Active comparator | Best available therapy at the discretion of the investigator, on a 28-day cycle. Receives: Drug: Best Available Therapy (BAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part A Only) Spleen Volume Reduction (SVR)
The proportion of subjects achieving a ≥ 35% spleen volume reduction (SVR) from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Measured: 24 weeks
(Part B Only) Spleen Volume Reduction (SVR)
The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)
Measured: 24 Weeks
Secondary outcomes (7)
(Part A only) Improvement in Total Symptom Score (TSS)
The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 and Week 48 in the total symptom score as measured by the modified MPN-SAF v2.0
Measured: 48 weeks
(Part B only) Improvement of Total Symptom Score (TSS)
The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 in the total symptom score as measured by the MF-SAF v4.0
Measured: 24 Weeks
(Part B only) Overall Survival (OS)
Time from randomization to death from any cause
Measured: 48 months
(Part B only) Progression free survival (PFS)
Time from randomization to either first occurrence of disease progression or death due to any cause
Measured: 48 months
(Part B Only) Overall Spleen Volume Reduction (SVR)
The proportion of subjects in each arm achieving SVR of ≥ 35% at any time by MRI/CT scan (central review)
Measured: 48 months
(Part B Only) Spleen Response Duration
Time from initial SVR of ≥ 35% by MRI/CT (central review) until the first occurrence of disease progression
Measured: 48 months
(Part B Only) Rate of conversion from RBC transfusion dependent to independent
The proportion of subjects who have RBC transfusion independence at week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start15 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Myelofibrosis (PMF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662126
- Sponsor's protocol ID
- KRT-232-101
- Acronym
- BOREAS
- Status last verified
- Apr 2023
- First submitted
- 5 Sep 2018
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Al-Ali, H.K.; Delgado, R.G.; Lange, A.; Pluta, A.; McLornan, D.; Vachhani, P.; Damaj, G.L.; Jost, P.J.; Rejto, L.; Hus, M.; et al. KRT-232, A First-In-Class, Murine Double Minute 2 Inhibitor, for Myelofibrosis Relapsed or Refractory to Janus-Associated Kinase Inhibitor Treatment. Eha. Libr. 2020, 295035, S215