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

Active:	No
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT03935555
Trial Phases:	Phase I	Protocol IDs:	PU-H71-01-003 (primary) NCI-2019-03010
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Samus Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03935555

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.

Objectives

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).

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