Trial record 1 of 1 for:
NCT 04485260
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
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| ClinicalTrials.gov Identifier: NCT04485260 |
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Recruitment Status :
Recruiting
First Posted : July 24, 2020
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 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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group 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 |
| Actual Study Start Date : | January 28, 2021 |
| Estimated Primary Completion Date : | October 2022 |
| Estimated Study Completion Date : | October 2024 |
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: 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)
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Drug: KRT-232
administered by mouth Drug: Ruxolitinib administered by mouth
Other Names:
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Primary Outcome Measures :
- For Phase 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.
- For Phase 2:To determine the spleen volume reduction (SVR) at Week 24 [ Time Frame: 6 months after last patient enrolled ]The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan
Secondary Outcome Measures :
- 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)
- 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
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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
| Contact: John Mei | 650-542-0136 | jmei@kartosthera.com |
Locations
Show 38 study locations
Sponsors and Collaborators
Kartos Therapeutics, Inc.
| 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: | 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 |