KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT03669965
Phase
PHASE2
Status
Unknown

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KRT-232 — DRUG
    KRT-232, administered by mouth
  • Ruxolitinib — DRUG
    Ruxolitinib per approved prescribing label

Study Details

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea. This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.

Key Dates

Start date
Jan 15, 2019
Status verified
Jul 2020
Primary completion
Apr 30, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Arm 1
    KRT-232 120mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
  • Experimental: Part A Arm 2
    KRT-232 240mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
  • Experimental: Part A Arm 3
    KRT-232 120mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
  • Experimental: Part B KRT-232 Arm
    Recommended KRT-232 dose and schedule from Part A
  • Active Comparator: Part B Ruxolitinib Arm
    Ruxolitinib per approved prescribing label
  • Experimental: Part A Arm 4b
    KRT-232 240mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
  • Experimental: Part A Arm 2b
    KRT-232 240mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)

Primary Outcome Measure

Proportion of patients with splenomegaly achieving a response at Week 32 [ Time Frame: 32 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
The Kirklin Clinic of UAB HospitalBirminghamAlabama35249-
University of Southern California Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Washington University School of MedicineSt LouisMissouri63110-
Gabrail Cancer CenterCantonOhio44718-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Birmingham, AL

By research site
The Kirklin Clinic of UAB Hospital· Birmingham, ALUniversity of Southern California Norris Comprehensive Cancer Center· Los Angeles, CAWashington University School of Medicine· St Louis, MOGabrail Cancer Center· Canton, OHThe Ohio State University Comprehensive Cancer Center· Columbus, OH

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