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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04485260
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kartos Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Myelofibrosis Drug: KRT-232 Drug: Ruxolitinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
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)
Drug: KRT-232
administered by mouth

Drug: Ruxolitinib
administered by mouth
Other Names:
  • Jakafi
  • Jakavi

Experimental: Part A, Arm 2, Cohort 1
KRT-232 by mouth once daily for Days 1-5, off treatment for Days 6-28 (28 day cycle)
Drug: KRT-232
administered by mouth

Drug: Ruxolitinib
administered by mouth
Other Names:
  • Jakafi
  • Jakavi




Primary Outcome Measures :
  1. To determine the KRT-232 RP2D in combination with ruxolitinib [ Time Frame: 15 months ]
    Dose 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.


Secondary Outcome Measures :
  1. To determine spleen response [ Time Frame: 43 months ]
    The 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)

  2. To determine the change in Total Symptom Score (TSS) based Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) [ Time Frame: 43 months ]
    The percentage change in TSS as measured by the MFSAF v4.0 at any time point from Baseline while on study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (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, 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

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): NCT04485260


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

Sponsors and Collaborators
Kartos Therapeutics, Inc.
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Responsible Party: Kartos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04485260    
Other Study ID Numbers: KRT-232-109
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020

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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