Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib

Status Terminated

Clinical Trial Summary

This is a multicenter, Phase 1b study with dose escalation and expansion cohorts designed to assess the safety, tolerability, PK, and preliminary efficacy of PU-H71 in subjects with PMF, Post-PV MF, Post-ET MF, taking stable doses of ruxolitinib.

Clinical Trial Description

The study will employ a standard 3+3 dose escalation design to determine maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), with additional subjects treated in a dose expansion cohort. The time period for collecting dose limiting toxicities (DLTs) is 1 cycle (21 days). ;

Study Design

Related Conditions & MeSH terms

Polycythemia
Polycythemia Vera
Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF)
Post-Polycythemia Vera Myelofibrosis (Post-PV MF)
Primary Myelofibrosis
Primary Myelofibrosis (PMF)
Thrombocythemia, Essential
Thrombocytosis

Clinical Trial Details

NCT number	NCT03935555
Study type	Interventional
Source	Samus Therapeutics, Inc.
Contact
Status	Terminated
Phase	Phase 1
Start date	August 12, 2019
Completion date	November 4, 2022

View Details

See also
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