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RECRUITING Phase 1

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

NCT04176198 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Nusivertib
  • DRUG Ruxolitinib
  • DRUG Momelotinib

Study Locations (20)

California

  • City of Hope — Duarte
  • University of Southern California — Los Angeles
  • Hoag Family Cancer Institute — Newport Beach

Florida

  • University of Florida Health Shands Cancer Hospital — Gainesville
  • University of Miami — Miami
  • Baptist Health - Miami Cancer Institute — Miami

New York

  • Roswell Park Comprehensive Cancer Center — Buffalo
  • Icahn School of Medicine at Mount Sinai — New York

Alabama

  • University of Alabama — Birmingham

Arizona

  • The University of Arizona Cancer Center — Tucson

Colorado

  • Blood Cancer Center — Denver

Connecticut

  • Yale School of Medicine — New Haven

Georgia

  • Emory University — Atlanta

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2019-12-16
Est. Completion 2030-04-30
Phase Phase 1

Sponsor

Sumitomo Pharma America

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04176198

The ClinicalTrials.gov registry entry for NCT04176198 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions — of which Nusivertib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04176198 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04176198 about?

NCT04176198 is a clinical study titled "A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis". 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.

What is the current status of trial NCT04176198?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2019-12-16. Estimated completion is 2030-04-30.

What conditions does trial NCT04176198 study?

This clinical trial studies the following conditions: Myelofibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04176198?

The interventions under investigation include: Nusivertib (DRUG), Ruxolitinib (DRUG), Momelotinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04176198?

This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04176198 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial