RECRUITING

KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

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Conditions

Primary Myelofibrosis (PMF)Post-Polycythemia Vera MF (Post-PV-MF)Post-Essential Thrombocythemia MF (Post-ET-MF)navtemadlin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF. This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.

Official Title

A Phase 2/3 Randomized, Controlled, Open-Label 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 Are Relapsed or Refractory to Janus Kinase (JAK) Inhibitor Treatment

Quick Facts

Study Start:2019-01-15
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03662126

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  2. * High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  3. * Failure of prior treatment with JAK inhibitor
  4. * ECOG ≤ 2
  1. * Prior splenectomy
  2. * Splenic irradiation within 3 months prior to randomization
  3. * History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
  4. * History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
  5. * Prior MDM2 inhibitor therapy or p53-directed therapy
  6. * Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
  7. * History of major organ transplant
  8. * Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)

Contacts and Locations

Study Contact

John Mei
CONTACT
650-542-0136
jmei@kartosthera.com
Yulia Khalina
CONTACT
908-656-2799
ykhalina@kartosthera.com

Study Locations (Sites)

The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35294
United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Stanford Cancer Center - Palo Alto
Stanford, California, 94305
United States
Innovative Clinical Research Institute
Whittier, California, 90603
United States
University Cancer Institute
Boynton Beach, Florida, 33426
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
United States
New York Presbyterian/Weill Cornell Medical Center
New York, New York, 10021
United States
Mt. Sinai
New York, New York, 10029
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

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

Study Start Date2019-01-15
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-01-15
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • navtemadlin

Additional Relevant MeSH Terms

  • Primary Myelofibrosis (PMF)
  • Post-Polycythemia Vera MF (Post-PV-MF)
  • Post-Essential Thrombocythemia MF (Post-ET-MF)