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Unknown status
Verified  2022-05 by Kartos Therapeutics, Inc.
Last known status was: Recruiting

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

ClinicalTrials.gov ID NCT04485260
Sponsor Kartos Therapeutics, Inc.
Information provided by Kartos Therapeutics, Inc. (Responsible Party)
Last Update Posted 2022-05-09
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Study Overview

Brief Summary
This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.
Official Title
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
Conditions
Myelofibrosis
Intervention / Treatment
  • Drug: KRT-232
  • Drug: Ruxolitinib
  • Drug: KRT-232
  • Drug: Ruxolitinib
Other Study ID Numbers
  • KRT-232-109
Study Start (Actual)
2021-01-28
Primary Completion (Estimated)
2022-10
Study Completion (Estimated)
2024-10
Enrollment (Estimated)
36
Study Type
Interventional
Phase
Phase 1Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: John Mei

Phone Number: 650-542-0136

Email: jmei@kartosthera.com

This study has 38 locations
United States
California Locations
Duarte, California, United States, 91010

Recruiting

City of Hope
Maryland Locations
Baltimore, Maryland, United States, 21205

Recruiting

John Hopkins University
Michigan Locations
Ann Arbor, Michigan, United States, 48109

Recruiting

University of Michigan
New York Locations
New York, New York, United States, 10029

Recruiting

Icahn School of Medicine at Mount Sinai
Ohio Locations
Cleveland, Ohio, United States, 44106

Recruiting

Cleveland Clinic
Pennsylvania Locations
Philadelphia, Pennsylvania, United States, 19111

Recruiting

Fox Chase Cancer Center
Texas Locations
Houston, Texas, United States, 77030

Recruiting

MD Anderson Cancer Center
Washington Locations
Seattle, Washington, United States, 98109

Recruiting

Fred Hutchinson Cancer Research Center
Australia
Adelaide, Australia

Recruiting

Royal Adelaide Hospital
Bulgaria
Pleven, Bulgaria

Recruiting

Dr. Georgi Stranski
Sofia, Bulgaria, 1431

Recruiting

Saint Ivan Rilski Hospital
Sofia, Bulgaria, 1431

Recruiting

University Mutiprofile Hospital Alexandrovska
France
Angers, France, 49933

Recruiting

Chu Angers
Le Mans, France, 72000

Recruiting

Centre Hospitalier du Mans
Marseille, France, 13009

Recruiting

Institut Paoli-Calmettes
Montpellier, France, 34295

Recruiting

CHU Saint Eloi
Paris, France

Recruiting

Hopital Saint Louis
Tours, France

Recruiting

CHU Tours - Hôpital Bretonneau
Cedex 9 Locations
Caen, Cedex 9, France, 14033

Recruiting

CHU de Caen
Germany
Aachen, Germany, 52074

Recruiting

Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Halle, Germany, 6120

Recruiting

Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie
Jena, Germany

Recruiting

Universitaetsklinikum Jena
Mainz, Germany, 55131

Recruiting

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik
Mutlangen, Germany, 73557

Recruiting

Stauferklinikum Schwäbisch Gmünd
Israel
Zerifin, Israel, 7033001

Recruiting

Shamir Medical Center ( Assaf Harofeh)
Italy
Bologna, Italy, 340136

Recruiting

Bologna University Hospital, Institute of Hematology
Catania, Italy, 95124

Recruiting

Universita degli Studi di Catania
Firenze, Italy, 50134

Recruiting

University of Florence
Meldola, Italy, 47014

Recruiting

Istituto Tumori della Romagna (IRST)
Varese, Italy, 21100

Recruiting

Ospedale di Circolo e Fondazione MacchiASST Sette Laghi
Poland
Kraków, Poland

Recruiting

Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie
Opole, Poland

Recruiting

Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii
Spain
Barcelona, Spain, 08035

Recruiting

d'Hebron University Hospital in Barcelona
Barcelona, Spain, 08916

Recruiting

Hospital Universitario Germans Trias i Pujol
Las Palmas De Gran Canaria, Spain

Recruiting

Hospital Universitario de Gran Canaria Doctor Negrin
Málaga, Spain, 29010

Recruiting

Hospital Virgen de la Victoria
Salamanca, Spain

Recruiting

Hospital Universitario de Salamanca
Zaragoza, Spain, 50012

Recruiting

Hospital de Dia Quiron Zaragoza
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO)
  • 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:

  • Patients who are positive for TP53 mutations
  • 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
Show less
Ages Eligible for Study
18 Years to 99 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: 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)
Intervention/Treatment Drug: KRT-232
  • administered by mouth

Drug: Ruxolitinib
  • administered by mouth

  • Other Names:
    • Jakafi
    • Jakavi
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinibDose limiting toxicities will be used to establish the MTD of KRT-232 in combination with ruxolitinib. Subsequently, RP2D will be based on safety and efficacy data of the combination.15 months
For Phase 2:To determine the spleen volume reduction (SVR) at Week 24The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan6 months after last patient enrolled
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
To determine spleen responseThe proportion of subjects achieving ≥35% SVR at any time point from Baseline while on study, as assessed by MRI (or by CT scan for applicable subjects)43 months
To determine the change in Total Symptom Score (TSS) based Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0)The percentage change in TSS as measured by the MFSAF v4.0 at any time point from Baseline while on study43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Kartos Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2020-07-21
First Submitted that Met QC Criteria
2020-07-21
First Posted
2020-07-24
Study Record Updates
Last Update Submitted that met QC Criteria
2022-05-05
Last Update Posted
2022-05-09
Last Verified
2022-05

More Information

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Keywords Provided by Kartos Therapeutics, Inc.
Additional Relevant MeSH Terms