Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
NCT ID: NCT04878003
Last Updated: 2022-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
52 participants
INTERVENTIONAL
2021-04-13
2025-10-31
Brief Summary
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The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
KRT-232
KRT-232, administration by mouth
Arm 2
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
TL-895
TL-895, administration by mouth
Interventions
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KRT-232
KRT-232, administration by mouth
TL-895
TL-895, administration by mouth
Eligibility Criteria
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Inclusion Criteria
* High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
* ECOG of 0 or 1
Exclusion Criteria
* Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
* Prior treatment with any JAK inhibitor
* Prior splenectomy
* Splenic irradiation within 24 weeks prior to randomization
* Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
* History of major organ transplant
* Grade 2 or higher QTc prolongation
* Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Innovative Clinical Research Institute
Glendale, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Gabrail Cancer Center
Canton, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Republican Scientific Practical Center of Radiation Medicine and Human Ecology
Belarus’, , Belarus
Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
Minsk, , Belarus
UMHAT Georgi Stranski
Pleven, , Bulgaria
Medical Centre Hipokrat N
Plovdiv, , Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, , Bulgaria
Military Medical Academy
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Hematologic Diseases
Sofia, , Bulgaria
JSC EVEX Hospitals
Kutaisi, , Georgia
LTD M.Zodelava Hematology Centre
Tbilisi, , Georgia
K.Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, , Georgia
Centro de Investigacion Medica Aquascalientes (CIMA)
Aguascalientes, , Mexico
Unidad de Investigacion CIMA SC
Chihuahua City, , Mexico
Centro de Investigacion Clinica de Oaxaca (CICLO)
Oaxaca City, , Mexico
Sociedad de Metabolismo Y Corazon - SOMECO
Veracruz, , Mexico
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Katowice, , Poland
Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej
Opole, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, , Poland
Botkin City Clinical Hospital
Moscow, , Russia
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, , Russia
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , Russia
Almazov National Medical Research Center
Saint Petersburg, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
Samara State Medical University
Samara, , Russia
Wits Baragwanath Clinical Hematology Department
Soweto, , South Africa
City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council
Dnipro, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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KRT-232-114
Identifier Type: -
Identifier Source: org_study_id
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