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Evaluation of Ruxolitinib in Combination With PU-H71 for Treatment of Myelofibrosis

NCT03373877 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-11-15

No results posted yet for this study

Summary

This is a multicenter 2-part, Phase 1b study designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of PU-H71 in subjects taking concomitant ruxolitinib. The first part (Dose Escalation) will employ a standard 3+3 dose escalation design to determine Maximum Tolerated Dose (MTD). The second part of the study (Dose Confirmation) will confirm the recommended Phase 2 dose (RP2D) in an expanded population.

Conditions

  • Myelofibrosis
  • Primary Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis

Interventions

DRUG

PU-H71

PU-H71 treatments will be administered by IV infusion on days 1, 8, and 15 of each 28-day cycle.

DRUG

Ruxolitinib

Dosing will be in accordance with current package insert and dose subject was on during study entry.

Sponsors & Collaborators

  • Samus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Morgan, MS, JD · Sponsor GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2019-10-17
Completion
2020-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373877 on ClinicalTrials.gov