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Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis

NCT03386214 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-01-06

No results posted yet for this study

Summary

Based on the investigators' preclinical data, the combination of pevonedistat and ruxolitinib may provide greater clinical responses in patients with myelofibrosis compared to ruxolitinib monotherapy via inhibition of NFκB in addition to JAK-STAT signaling.

Conditions

  • Myelofibroses

Interventions

DRUG

Pevonedistat

The amount of pevonedistat to be administered will be based on body surface area (BSA). BSA will be calculated using a standard formula on Cycle 1 Day 1, and on Day 1 of subsequent cycles if the patient experiences a \> 5% change in body weight from the weight used for the most recent BSA calculation.

DRUG

Ruxolitinib

-Standard of care outside of protocol

PROCEDURE

Peripheral blood draw

* Baseline or Cycle 1 Day 1 (prior to study treatment administration) * Cycle 2 Day 1 (prior to study treatment administration) * Cycle 4 Day 1 (prior to study treatment administration) * End of treatment

PROCEDURE

Skin biopsy

A skin punch biopsy specimen will be collected at the baseline visit. One 6 mm punch biopsy of normal skin will be performed using standard techniques and local anesthesia.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Stephen Oh, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2021-09-12
Completion
2021-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03386214 on ClinicalTrials.gov