Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

May 5, 2022 updated by: Kartos Therapeutics, Inc.

An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)

The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belarus
      • Belarus, Belarus, 246040
        • Recruiting
        • Republican Scientific Practical Center of Radiation Medicine and Human Ecology
      • Minsk, Belarus, 220045
        • Recruiting
        • Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • UMHAT Georgi Stranski
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Medical Centre Hipokrat N
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Military Medical Academy
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Umhat Sv. Ivan Rilski Ead
      • Sofia, Bulgaria, 1756
        • Recruiting
        • Specialized Hospital for Active Treatment of Hematologic Diseases
  • Georgia
      • Kutaisi, Georgia, 4600
        • Recruiting
        • JSC Evex Hospitals
      • Tbilisi, Georgia, 112
        • Recruiting
        • LTD M.Zodelava Hematology Centre
      • Tbilisi, Georgia, 159
        • Recruiting
        • K.Eristavi National Center of Experimental and Clinical Surgery
  • Mexico
      • Aguascalientes, Mexico, 20116
        • Recruiting
        • Centro de Investigacion Medica Aquascalientes (CIMA)
      • Chihuahua, Mexico, 31200
        • Recruiting
        • Unidad de Investigacion CIMA SC
      • Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca (CICLO)
      • Veracruz, Mexico, 91900
        • Recruiting
        • Sociedad de Metabolismo Y Corazon - SOMECO
  • Poland
      • Katowice, Poland, 40-519
        • Recruiting
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
      • Opole, Poland, 45-061
        • Recruiting
        • Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej
      • Słupsk, Poland, 76-200
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
  • Russian Federation
      • Moscow, Russian Federation, 125284
        • Recruiting
        • Botkin City Clinical Hospital
      • Petrozavodsk, Russian Federation, 185019
        • Recruiting
        • Republican Hospital n.a. V.A. Baranov
      • Saint Petersburg, Russian Federation, 197341
        • Recruiting
        • Almazov National Medical Research Centre
      • Saint Petersburg, Russian Federation, 197022
        • Recruiting
        • Pavlov First Saint Petersburg State Medical University
      • Saint Petersburg, Russian Federation, 197341
        • Recruiting
        • Almazov National Medical Research Center
      • Samara, Russian Federation, 443099
        • Recruiting
        • Samara State Medical University
  • South Africa
      • Soweto, South Africa, 1519
        • Recruiting
        • Wits Baragwanath Clinical Hematology Department
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Recruiting
        • City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council
  • United States
    • California
      • Glendale, California, United States, 90603
        • Recruiting
        • Innovative Clinical Research Institute
      • Whittier, California, United States, 90603
        • Recruiting
        • Innovative Clinical Research Institute
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  • High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
  • ECOG of 0 or 1

Exclusion Criteria:

  • Subjects who are positive for p53 mutation (Arm 1)
  • Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
  • Prior treatment with any JAK inhibitor
  • Prior splenectomy
  • Splenic irradiation within 24 weeks prior to randomization
  • Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
  • History of major organ transplant
  • Grade 2 or higher QTc prolongation
  • Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
Drug: KRT-232
KRT-232, administration by mouth
Experimental: Arm 2
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
Drug: TL-895
TL-895, administration by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spleen Volume Reduction (SVR)
Time Frame: 24 weeks
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Total Symptom Score (TSS)
Time Frame: 24 weeks
The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 in the total symptom score as measured by the MF-SAF v4.0
24 weeks
Spleen Response Duration
Time Frame: 48 months
Time from initial SVR of ≥35% by MRI/CT (central review) until progression
48 months
Rate of conversion from RBC transfusion dependent to independent
Time Frame: 24 weeks
The proportion of subjects who convert from transfusion dependent to transfusion independent at Week 24
24 weeks
Overall Survival (OS)
Time Frame: 48 months
Time from first dose to death from any cause
48 months
Progression free survival (PFS)
Time Frame: 48 months
Time from randomization to either first occurrence of disease progression or death due to any cause
48 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 Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRT-232-114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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