Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
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| ClinicalTrials.gov Identifier: NCT04878003 |
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Recruitment Status :
Recruiting
First Posted : May 7, 2021
Last Update Posted : May 9, 2022
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Sponsor:
Kartos Therapeutics, Inc.
Information provided by (Responsible Party):
Kartos Therapeutics, Inc.
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Essential thrombocythemia
Primary myelofibrosis
Polycythemia vera
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: KRT-232
KRT-232, administration by mouth |
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Experimental: Arm 2
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
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Drug: TL-895
TL-895, administration by mouth |
Primary Outcome Measures :
- 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 :
- 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
- Spleen Response Duration [ Time Frame: 48 months ]Time from initial SVR of ≥35% by MRI/CT (central review) until progression
- 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
- Overall Survival (OS) [ Time Frame: 48 months ]Time from first dose to death from any cause
- 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
| Contact: John Mei | 650-542-0136 | jmei@kartosthera.com | |
| Contact: Jordan Blevins | 650-542-0136 | jblevins@kartosthera.com |
Locations
Show 29 study locations
Sponsors and Collaborators
Kartos Therapeutics, Inc.
| 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 9, 2022 |
| Last Verified: | May 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Kartos Therapeutics, Inc.:
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navtemadlin |
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 |