A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

Conditions

• Myelofibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nusivertib — DRUG
  Oral PIM Inhibitor
• Ruxolitinib — DRUG
  Oral JAK inhibitor
• Momelotinib — DRUG
  Oral JAK inhibitor

Study Details

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

Key Dates

Start date

Dec 16, 2019

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2030

Study Design

Enrollment

240 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: nuvisertib (TP-3654)
• Experimental: Arm 2: nuvisertib (TP-3654) added on to ruxolitinib
• Experimental: Arm 3: nuvisertib (TP-3654) in combination with momelotinib

Primary Outcome Measure

Determine the incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts

• Reyna Bishop
  617-674-6800
  [email protected]
• Jordan Simpson
  [email protected]

Locations (32)

Find similar trials in Birmingham, AL

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