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NCT04176198RECRUITINGIRB Ready

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

Sponsored by Sumitomo Pharma America, Inc.

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

to be eligible: Nuvisertib (TP-3654) Monotherapy Arm:
Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF and intermediate or high-risk primary or secondary MF
Previously treated with JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor
Fulfill the following clinical laboratory parameters:
Platelet count โ‰ฅ 25 x 10\^9 /L, without assistance of growth factors or platelet transfusions
ANC โ‰ฅ 1 x 10\^9/L without assistance of granulocyte growth factors
Peripheral blood blast count \< 5%
ECOG performance status โ‰ค 1
Life expectancy โ‰ฅ 6 months
Adequate renal function
Adequate hepatic function
Adequate coagulation function
Splenomegaly (spleen volume of โ‰ฅ 450 cm3 by MRI or CT scan) within 2 weeks prior to Cycle 1 Day 1.
Dose escalation: At least 2 symptoms measurable (score

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

240 participants

โšง

Gender

ALL

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Sponsor

Sumitomo Pharma America, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Duarte

California

Location available
View Duarte location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Newport Beach

California

Location available
View Newport Beach location page
RECRUITING

Denver

Colorado

Location available
View Denver location page
NOT_YET_RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
COMPLETED

Gainesville

Florida

Location available
View Gainesville location page
RECRUITING

Miami

Florida

Location available
View Miami location page

๐Ÿ“ And 23 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Myelofibrosis Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Myelofibrosis Treatment Options in Birmingham, Alabama

If you're searching for Myelofibrosis treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Tucson, Duarte and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Myelofibrosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 240 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Myelofibrosis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Myelofibrosis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Myelofibrosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04176198. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.