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

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ClinicalTrials.gov Identifier: NCT04878003
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Kartos Therapeutics, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary Myelofibrosis (PMF) Post-Polycythemia Vera Myelofibrosis (Post-PV-MF) Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF) Drug: KRT-232 Drug: TL-895 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : October 2025


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




Primary Outcome Measures :
  1. Spleen Volume Reduction (SVR) [ Time Frame: 24 weeks ]
    The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)


Secondary Outcome Measures :
  1. 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

  2. Spleen Response Duration [ Time Frame: 48 months ]
    Time from initial SVR of ≥35% by MRI/CT (central review) until progression

  3. 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

  4. Overall Survival (OS) [ Time Frame: 48 months ]
    Time from first dose to death from any cause

  5. Progression free survival (PFS) [ Time Frame: 48 months ]
    Time from randomization to either first occurrence of disease progression or death due to any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878003


Contacts
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Contact: John Mei 650-542-0136 jmei@kartosthera.com
Contact: Jordan Blevins 650-542-0136 jblevins@kartosthera.com

Locations
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United States, California
Innovative Clinical Research Institute Recruiting
Glendale, California, United States, 90603
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Kartos Therapeutics, Inc.
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Responsible Party: Kartos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04878003    
Other Study ID Numbers: KRT-232-114
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders