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MDM2 Inhibitor

KRT-232 + Ruxolitinib for Myelofibrosis

Phase 1 & 2

Recruiting

Research Sponsored by Kartos Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 43 months

Awards & highlights

Study Summary

This trial is testing a new drug combination for myelofibrosis, a rare blood cancer. The goal is to find the best dose of the new drug to give with another drug that is already used for this disease.

Who is the study for?

This trial is for patients with Primary Myelofibrosis, Post-Polycythemia Vera MF, or Post-Essential Thrombocythemia MF who haven't had the best results from Ruxolitinib. They should have been on Ruxolitinib for at least 18 weeks and be stable on it for the last 8 weeks. Their spleen must be enlarged and they need to have certain symptoms related to their condition.Check my eligibility

What is being tested?

The study tests KRT-232 combined with Ruxolitinib in patients whose Myelofibrosis hasn't responded well enough to just Ruxolitinib. The goal is to find a safe and effective dose of KRT-232 that works alongside Ruxolitinib.See study design

What are the potential side effects?

Possible side effects include issues like nausea, vomiting, diarrhea, fatigue, changes in blood counts leading to increased risk of infections or bleeding problems, liver function abnormalities, and potential skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spleen is enlarged, measuring over 5 cm below the ribcage or over 450 cm3 on imaging.

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I have at least 2 symptoms that affect my daily life.

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I can care for myself and am up and about more than half of my waking hours.

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I have been diagnosed with a form of myelofibrosis according to WHO standards.

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I have been on ruxolitinib for at least 18 weeks and my dose has not changed in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 43 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~43 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinib

For Phase 2:To determine the spleen volume reduction (SVR) at Week 24

Secondary outcome measures

To determine spleen response

To determine the change in Total Symptom Score (TSS) based Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part A, Arm 1, Cohort 1Experimental Treatment2 Interventions

KRT-232 by mouth once daily for Days 1-7, off treatment for Days 8-28 (28 day cycle)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kartos Therapeutics, Inc.Lead Sponsor

15 Previous Clinical Trials

1,414 Total Patients Enrolled

Media Library

KRT-232 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04485260 — Phase 1 & 2

Myelofibrosis Research Study Groups: Part A, Arm 1, Cohort 1

Myelofibrosis Clinical Trial 2023: KRT-232 Highlights & Side Effects. Trial Name: NCT04485260 — Phase 1 & 2

KRT-232 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485260 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial offer opportunity to minors?

"According to the data, this medical trial is available for patients aged 18-99. There are 33 additional trials specifically targeting those under eighteen and 226 designed with seniors in mind."

Answered by AI

How many subjects are being administered treatment within this experiment?

"The sponsor, Kartos Therapeutics, Inc., will be overseeing this trial at various medical centres such as Icahn School of Medicine at Mount Sinai in New york and University of Michigan in Ann Arbor. In total, 36 patients who fit the criteria must be recruited to facilitate its execution."

Answered by AI

Is recruitment still open for this clinical experiment?

"Affirmative. According to the clinicaltrials.gov database, this study is seeking participants and has been since its initial posting on January 28th 2021. The experiment was recently updated on May 5th 2022 and requires 36 people from 8 different sites for enrollment."

Answered by AI

What criteria must one meet in order to take part in this research endeavor?

"This medical research is currently looking for 36 individuals between the ages of 18 and 99 with a primary myelofibrosis diagnosis. To be eligible, the applicant must have been treated with ruxolitinib for more than 18 weeks prior to study entry and remain on stable dosages in the 8 week period leading up to enrollment. Additionally, spleen size needs to exceed 5 cm below lower left costal margin or 450 cm3 using MRI/CT scans; symptoms need to score at least 1 on MFSAF v4.0; and performance status should display an ECOG rating from 0-2."

Answered by AI

What conditions are typically treated with KRT-232?

"KRT-232 has been approved for the treatment of polycythemia vera, as well as hydroxyurea resistant or intolerant forms of polycythemia and primary myelofibrosis."

Answered by AI

What precedent has been set by prior investigations utilizing KRT-232?

"KRT-232 was initially studied at the National Institutes of Health Clinical Center in 2002, with 96 trials having been completed by now. Currently, 109 studies are actively recruiting and many of these are centered around New york City."

Answered by AI

How many medical institutions are engaged in this experiment?

"This scientific investigation is being conducted out of the Icahn School of Medicine at Mount Sinai in New york, University of Michigan in Ann Arbor, and MD Anderson Cancer Center in Houston. Additionally, 8 other locations are involved with this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04485260.

All > Essential Thrombocythemia > Polycythemia Vera