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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03662126
Registration number
NCT03662126
Ethics application status
Date submitted
5/09/2018
Date registered
7/09/2018
Date last updated
28/04/2023
Titles & IDs
Public title
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
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Scientific 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
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Secondary ID [1]
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0
KRT-232-101
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Universal Trial Number (UTN)
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Trial acronym
BOREAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Myelofibrosis (PMF)
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0
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Post-Polycythemia Vera MF (Post-PV-MF)
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0
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Post-Essential Thrombocythemia MF (Post-ET-MF)
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0
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Condition category
Condition code
Blood
0
0
0
0
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Haematological diseases
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Blood
0
0
0
0
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Other blood disorders
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Musculoskeletal
0
0
0
0
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
0
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0
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Other human genetics and inherited disorders
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Cancer
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0
0
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - KRT-232
Treatment: Drugs - Best Available Therapy (BAT)
Experimental: Part A Cohort 1 - KRT-232 120 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Experimental: Part A Cohort 2 - KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Experimental: Part A Cohort 3 - KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Experimental: Part A Cohort 4b - KRT-232 240 mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
Experimental: Part B Arm 1 KRT-232 - KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Active comparator: Part B Arm 2 Best Available Therapy - Best available therapy at the discretion of the investigator, on a 28-day cycle.
Treatment: Drugs: KRT-232
KRT-232, administered by mouth
Treatment: Drugs: Best Available Therapy (BAT)
Best available therapy options include:
1. hydroxyurea
2. chemotherapy or
3. supportive care (including but not limited to corticosteroids and androgens; JAK inhibitors not allowed).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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(Part A Only) Spleen Volume Reduction (SVR)
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Assessment method [1]
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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
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Timepoint [1]
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24 weeks
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Primary outcome [2]
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(Part B Only) Spleen Volume Reduction (SVR)
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Assessment method [2]
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The proportion of subjects achieving SVR of = 35% at Week 24 by MRI/CT scan (central review)
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Timepoint [2]
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24 Weeks
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Secondary outcome [1]
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(Part A only) Improvement in Total Symptom Score (TSS)
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Assessment method [1]
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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
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Timepoint [1]
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48 weeks
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Secondary outcome [2]
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(Part B only) Improvement of Total Symptom Score (TSS)
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Assessment method [2]
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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
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Timepoint [2]
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24 Weeks
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Secondary outcome [3]
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(Part B only) Overall Survival (OS)
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Assessment method [3]
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Time from randomization to death from any cause
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Timepoint [3]
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48 months
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Secondary outcome [4]
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(Part B only) Progression free survival (PFS)
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Assessment method [4]
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Time from randomization to either first occurrence of disease progression or death due to any cause
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Timepoint [4]
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48 months
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Secondary outcome [5]
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0
(Part B Only) Overall Spleen Volume Reduction (SVR)
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Assessment method [5]
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The proportion of subjects in each arm achieving SVR of = 35% at any time by MRI/CT scan (central review)
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Timepoint [5]
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48 months
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Secondary outcome [6]
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(Part B Only) Spleen Response Duration
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Assessment method [6]
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Time from initial SVR of = 35% by MRI/CT (central review) until the first occurrence of disease progression
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Timepoint [6]
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48 months
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Secondary outcome [7]
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(Part B Only) Rate of conversion from RBC transfusion dependent to independent
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Assessment method [7]
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The proportion of subjects who have RBC transfusion independence at week 24
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Timepoint [7]
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24 weeks
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
385
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Fiona Stanley Hosital - Murdoch
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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The Alfred Hospital - Melbourne
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Recruitment hospital [5]
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South Eastern Private Hospital - Noble Park
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Recruitment hospital [6]
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Icon Cancer Center - South Brisbane
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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6150 - Murdoch
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Melbourne
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Recruitment postcode(s) [5]
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3174 - Noble Park
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Recruitment postcode(s) [6]
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- South Brisbane
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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Florida
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Illinois
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Massachusetts
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United States of America
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Missouri
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United States of America
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United States of America
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Ohio
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Oregon
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South Dakota
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United States of America
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Tennessee
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Texas
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Argentina
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Santa Fe
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Córdoba
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Ceara
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Brazil
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Parana
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Brazil
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Brazil
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Goiânia
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Jau
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Brazil
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Porto Alegre
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Brazil
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Sao Paulo
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Pleven
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Sofia
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Ontario
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Sibenik
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Zagreb
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Králová
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Nové Mesto
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Olomouc
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Bayonne
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Germany
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Germany
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Germany
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Germany
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Germany
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Mainz
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Germany
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Germany
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Saarbrücken
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Ioannina
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Patras
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Thessaloníki
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Hong Kong
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Hong Kong
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Shatin
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Hungary
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Somogy
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Hungary
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Szabolcs-Szatmar-Bereg
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Hungary
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Vas
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Hungary
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Hungary
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Debrecen
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Hungary
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Szeged
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Israel
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Afula
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Israel
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Ashdod
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Nahariya
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Israel
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Zerifin
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Italy
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Lombardia
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Italy
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Alessandria
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Italy
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Ancona
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Italy
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Catania
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Italy
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Firenze
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Italy
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Meldola
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Italy
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Novara
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Italy
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Pesaro
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Torino
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Iasi
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Timisoara
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Romania
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Târgu-Mures
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Russian Federation
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Omsk
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Russian Federation
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St Petersburg
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Russian Federation
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Syktyvkar
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Spain
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Barcelona
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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Cáceres
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Málaga
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Salamanca
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Valencia
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Zaragoza
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Taiwan
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Taipei
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Thailand
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Bangkok
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Thailand
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Khlong Luang
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Thailand
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Khon Kaen
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Thailand
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Songkhla
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Turkey
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Adapazari
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Turkey
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Ankara
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Turkey
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Denizli
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Turkey
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Gaziantep
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Turkey
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Malatya
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Turkey
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Mersin
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Turkey
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Samsun
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United Kingdom
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Birmingham
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Oxford
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Funding & Sponsors
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Commercial sector/industry
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Name
Kartos Therapeutics, Inc.
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT03662126
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Trial related presentations / 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
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Public notes
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Contacts
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Contact person for public queries
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John Mei
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Phone
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650-542-0136
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
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https://clinicaltrials.gov/study/NCT03662126
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