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Small Molecule Inhibitor

KRT-232 for Polycythemia Vera

Phase 2
Waitlist Available
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new drug, KRT-232, to treat patients with PV who can't take hydroxyurea or who have tried interferon. The trial has 2 parts. In the first part, patients will be given different doses and schedules of KRT-232. In the second part, patients will be given KRT-232 or ruxolitinib.

Eligible Conditions
  • Polycythemia Vera

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with splenomegaly achieving a response at Week 32
Secondary outcome measures
Change from baseline of EORTC-QLQ-C30 patient-reported outcome
Change from baseline of MPN-SAF TSS v2.0 patient-reported outcome
Duration of response after achieving both the absence of phlebotomy eligibility and reduction in spleen volume (for patients with splenomegaly)
+1 more
Other outcome measures
Proportion of patients without splenomegaly achieving the absence of phlebotomy eligibility beginning at the Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post-randomization and prior to Week 8

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Part B KRT-232 ArmExperimental Treatment1 Intervention
Recommended KRT-232 dose and schedule from Part A
Group II: Part A Arm 4bExperimental Treatment1 Intervention
KRT-232 240mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
Group III: Part A Arm 3Experimental Treatment1 Intervention
KRT-232 120mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Group IV: Part A Arm 2bExperimental Treatment1 Intervention
KRT-232 240mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Group V: Part A Arm 2Experimental Treatment1 Intervention
KRT-232 240mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Group VI: Part A Arm 1Experimental Treatment1 Intervention
KRT-232 120mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Group VII: Part B Ruxolitinib ArmActive Control1 Intervention
Ruxolitinib per approved prescribing label

Find a Location

Who is running the clinical trial?

Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,430 Total Patients Enrolled
3 Trials studying Polycythemia Vera
473 Patients Enrolled for Polycythemia Vera

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera
2019. "KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03669965.
All > Polycythemia Vera
~3 spots leftby Apr 2025
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