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

NCT ID: NCT03669965

Last Updated: 2020-07-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycythemia Vera

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A Arm 1

KRT-232 120mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Group Type EXPERIMENTAL

KRT-232

Intervention Type DRUG

KRT-232, administered by mouth

Part A Arm 2

KRT-232 240mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)

Group Type EXPERIMENTAL

KRT-232

Intervention Type DRUG

KRT-232, administered by mouth

Part A Arm 3

KRT-232 120mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)

Group Type EXPERIMENTAL

KRT-232

Intervention Type DRUG

KRT-232, administered by mouth

Part B KRT-232 Arm

Recommended KRT-232 dose and schedule from Part A

Group Type EXPERIMENTAL

KRT-232

Intervention Type DRUG

KRT-232, administered by mouth

Part B Ruxolitinib Arm

Ruxolitinib per approved prescribing label

Group Type ACTIVE_COMPARATOR

Ruxolitinib

Intervention Type DRUG

Ruxolitinib per approved prescribing label

Part A Arm 4b

KRT-232 240mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)

Group Type EXPERIMENTAL

KRT-232

Intervention Type DRUG

KRT-232, administered by mouth

Part A Arm 2b

KRT-232 240mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)

Group Type EXPERIMENTAL

KRT-232

Intervention Type DRUG

KRT-232, administered by mouth

Interventions

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KRT-232

KRT-232, administered by mouth

Intervention Type DRUG

Ruxolitinib

Ruxolitinib per approved prescribing label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kartos Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

Site Status

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Gabrail Cancer Center

Canton, Ohio, United States

Site Status

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Center Hospitalier Universitaire d'Angers

Angers, , France

Site Status

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

Dresden, Saxony, Germany

Site Status

Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Site Status

Stauferklinikum Schwäbisch Gmünd

Mutlangen, , Germany

Site Status

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

Gyula, , Hungary

Site Status

Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Szpital Wojewódzki w Opolu

Opole, , Poland

Site Status

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status

Countries

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United States France Germany Hungary Poland Spain

Other Identifiers

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KRT-232-102

Identifier Type: -

Identifier Source: org_study_id

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