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

Part of paid clinical trials in Duarte, California.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT04485260
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • KRT-232 — DRUG
    administered by mouth
  • Ruxolitinib — DRUG
    administered by mouth

Study Details

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.

Key Dates

Start date
Jan 28, 2021
Status verified
May 2022
Primary completion
Oct 31, 2022
Completion
Oct 31, 2024

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinib [ Time Frame: 15 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
John Hopkins UniversityBaltimoreMaryland21205-
University of MichiganAnn ArborMichigan48109-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Cleveland ClinicClevelandOhio44106-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAJohn Hopkins University· Baltimore, MDUniversity of Michigan· Ann Arbor, MIIcahn School of Medicine at Mount Sinai· New York, NYCleveland Clinic· Cleveland, OHFox Chase Cancer Center· Philadelphia, PA

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