NCT03386214

Pevonedistat in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-04-23
• Primary completion: 2021-09-12
• Completion: 2021-10-04
• First posted: 2017-12-29
• Last updated: 2022-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study