A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

Conditions

• MPN (Myeloproliferative Neoplasms)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Parsaclisib — DRUG
  Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
• Parsaclisib — DRUG
  Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
• Ruxolitinib — DRUG
  The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
• Parsaclisib — DRUG
  20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.
• Parsaclisib — DRUG
  2 dose strategies will be compared: 1. 5 mg parsaclisib beginning on Day 1 until end of treatment. 2. 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.

Study Details

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.

Key Dates

Start date

Feb 8, 2017

Status verified

Apr 2024

Primary completion

Jan 28, 2021

Completion

Apr 29, 2022

Study Design

Enrollment

74 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Ruxolitinib + Parsaclisib
  Initial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
• Experimental: Part 2: Ruxolitinib + Parsaclisib
  Part 2 will compare 2 doses of parsaclisib .
• Experimental: Part 3: Ruxolitinib + Parsaclisib
  Part 3 will compare 2 different long term dosing strategies.
• Experimental: Part 4: Ruxolitinib + Parsaclisib
  Part 4 will compare 2 different daily dosing strategies.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: up to Day 28 ]

Locations (39)

Find similar trials in Birmingham, AL

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• MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)
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