KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

Running, not enrolling · Phase 2

Conditions studied: Polycythemia Vera

In brief

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea. This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.

Key facts

Study ID

NCT03669965

Run by

Kartos Therapeutics, Inc.

People needed

20

Starts

2019-01-15

Expected to finish

2022-10-01

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of PV (WHO 2016)
• ECOG ≤ 2
• Part A: patients with and without splenomegaly are eligible
• Part A: patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon
• Part B: only patients with splenomegaly are eligible
• Part B: patients must be resistant or intolerant to hydroxyurea

You may not qualify if…

• Diagnosis of post-PV myelofibrosis (IWG-MRT)
• Prior treatment with MDM2 inhibitors, p53-directed therapies, HDAC, BCL 2 inhibitors
• Splenic irradiation within 3 months prior to the first dose of study treatment
• Clinically significant thrombosis within 3 months of screening
• Grade 2 or higher QTc prolongation
• Part B: prior treatment with a JAK inhibitor

Where it is running

• The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States
• University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Center Hospitalier Universitaire d'Angers — Angers, France
• Universitätsklinikum Aachen — Aachen, North Rhine-Westphalia, Germany
• Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle — Dresden, Saxony, Germany
• Universitätsklinikum Carl Gustav Carus — Dresden, Saxony, Germany
• Stauferklinikum Schwäbisch Gmünd — Mutlangen, Germany
• Békés Megyei Központi Kórház Pándy Kálmán Tagkórház — Gyula, Hungary
• Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku — Wroclaw, Lower Silesian Voivodeship, Poland
• Szpital Wojewódzki w Opolu — Opole, Poland
• Hospital Universitario de Gran Canaria Doctor Negrin — Las Palmas de Gran Canaria, LAS Palmas, Spain
• Hospital Universitario Virgen de la Victoria — Málaga, Spain
• Hospital Universitario de Salamanca — Salamanca, Spain

Full record on ClinicalTrials.gov

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