Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis

PHASE1TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

April 23, 2018

Primary Completion Date

September 12, 2021

Study Completion Date

October 4, 2021

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.

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT03386214 - Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis | Biotech Hunter | Biotech Hunter