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
NCT ID: NCT04485260
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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UNKNOWN
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2021-01-28
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part A, Arm 1, Cohort 1
KRT-232 by mouth once daily for Days 1-7, off treatment for Days 8-28 (28 day cycle)
KRT-232
administered by mouth
Ruxolitinib
administered by mouth
Interventions
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KRT-232
administered by mouth
Ruxolitinib
administered by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry
* Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT
* Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0
* ECOG performance status of 0 to 2
Exclusion Criteria
* Documented disease progression or clinical deterioration any time while on ruxolitinib treatment
* Patients who have had a documented spleen response to ruxolitinib.
* Prior splenectomy
* Prior MDM2 inhibitor therapy or p53-directed therapy
18 Years
99 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
John Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, , Australia
Dr. Georgi Stranski
Pleven, , Bulgaria
Saint Ivan Rilski Hospital
Sofia, , Bulgaria
University Mutiprofile Hospital Alexandrovska
Sofia, , Bulgaria
CHU de Caen
Caen, Cedex 9, France
Chu Angers
Angers, , France
Centre Hospitalier du Mans
Le Mans, , France
Institut Paoli-Calmettes
Marseille, , France
CHU Saint Eloi
Montpellier, , France
Hopital Saint Louis
Paris, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Aachen, , Germany
Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie
Halle, , Germany
Universitaetsklinikum Jena
Jena, , Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik
Mainz, , Germany
Stauferklinikum Schwäbisch Gmünd
Mutlangen, , Germany
Shamir Medical Center ( Assaf Harofeh)
Ẕerifin, , Israel
Bologna University Hospital, Institute of Hematology
Bologna, , Italy
Universita degli Studi di Catania
Catania, , Italy
University of Florence
Florence, , Italy
Istituto Tumori della Romagna (IRST)
Meldola, , Italy
Ospedale di Circolo e Fondazione MacchiASST Sette Laghi
Varese, , Italy
Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie
Krakow, , Poland
Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii
Opole, , Poland
d'Hebron University Hospital in Barcelona
Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital de Dia Quiron Zaragoza
Zaragoza, , Spain
Countries
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Central Contacts
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Other Identifiers
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KRT-232-109
Identifier Type: -
Identifier Source: org_study_id
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