KRT-232 in Subjects With PMF, Post-PV MF, or Post-ET MF Who Have Failed a JAK Inhibitor



Status:Recruiting
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:January 15, 2019
End Date:February 28, 2023
Contact:John Mei
Email:jmei@kartosthera.com
Phone:650-542-0136

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An Open-Label, Phase 2a/2b 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 Have Failed a JAK Inhibitor

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 JAK
inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.

This study is a global, open-label Phase 2 study to determine the efficacy and safety of
KRT-232 in patients with primary MF, post-polycythemia vera MF, or post-essential
thrombocythemia MF who have failed previous treatment with JAK inhibitor (Part A), or
Ruxolitinib (Part B). In Part A of the study, patients will be randomly assigned to 2
different doses and 2 different dosing schedules of KRT-232. In Part B of the study, patients
will be treated at the recommended dose and schedule from Part A.


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 (Part A) or ruxolitinib (Part B)

- ECOG ≤ 2

Exclusion Criteria:

- Prior splenectomy

- Splenic irradiation within 3 months prior to the first dose of KRT-232

- Active or chronic bleeding within 4 weeks prior to the first dose of KRT-232

- Prior MDM2 inhibitor therapy or p53-directed therapy

- Prior treatment with HDAC or BCL-2 inhibitors

- Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version
5.0)
We found this trial at
13
sites
Florham Park, New Jersey 07932
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-346-0227
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6685
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Boynton Beach, Florida 33426
Phone: 561-737-6556
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Boynton Beach, FL
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Canton, OH
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Phone: 312-996-5931
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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Columbus, Ohio 43210
Phone: 614-293-7807
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Columbus, OH
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La Jolla, California 92093
Phone: 858-534-5201
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La Jolla, CA
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Los Angeles, California 90033
Phone: 323-865-3000
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Los Angeles, CA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-362-9236
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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640 Jackson Street
Saint Paul, Minnesota 55101
Phone: 651-254-3391
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Saint Paul, MN
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Toronto, Ontario
Phone: 416-946-5178
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Toronto,
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Whittier, California 90603
Phone: 562-693-4477
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Whittier, CA
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