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Oral TP-3654 for Myelofibrosis

Phase 1 & 2

Recruiting

Research Sponsored by Sumitomo Dainippon Pharma Oncology, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Splenomegaly during the screening period as demonstrated by splenic length ≥ 5 cm below the costal margin by palpation or spleen volume of ≥ 450 cm3 by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) scan

- Adequate renal function, as determined by clinical laboratory tests (serum creatinine ≤ 1.5 x upper limit of normal (ULN), and calculated creatinine clearance ≥ 30 mL/min) (Cockcroft-Gault)

Must not have

Received previous systemic antineoplastic therapy (including unconjugated therapeutic antibodies, toxin immunoconjugates, ESA, and alpha-interferon) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment

Splenic irradiation within 6 months prior to Screening or prior splenectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is to test a new drug for people with a certain type of cancer. The study will see if the drug is safe and if it works.

Who is the study for?

This trial is for adults with primary or secondary myelofibrosis, a type of bone marrow cancer. They must have tried and failed JAK inhibitor treatment or be ineligible for it. Participants need to have certain blood counts, organ function within specific limits, and a life expectancy of at least 3 months. They can't join if they've had recent surgeries or other treatments that could interfere with the study.

What is being tested?

The trial is testing TP-3654, an oral medication for myelofibrosis patients who are at intermediate or high risk. It's in early stages (Phase 1/2) to see how safe it is and how the body responds to different doses. Patients will also undergo regular bone marrow biopsies to monitor effects.

What are the potential side effects?

Since this is an early-phase trial assessing safety and tolerability, exact side effects aren't listed but may include typical reactions such as nausea, fatigue, liver issues based on similar drugs' profiles; close monitoring will identify any potential adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spleen is enlarged, confirmed by a doctor's exam or imaging tests.

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My kidney function is within the required range.

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I can take care of myself but might not be able to do heavy physical work.

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I have at least 2 symptoms of my condition that can be measured.

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My liver functions and blood clotting levels are within the required range.

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My recent tests show significant scarring in my bone marrow.

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I have been diagnosed with a type of myelofibrosis and it's considered intermediate or high-risk.

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My white blood cell count is healthy without needing medication to help.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment or experimental therapy in the last 14 days or 5 half-lives, whichever is longer.

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I have had my spleen removed or received spleen radiation in the last 6 months.

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I am eligible for a bone marrow or stem cell transplant within 3 months after joining.

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I do not have brain cancer, cancer spread to the brain, or any condition affecting my nervous system.

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I have taken hydroxyurea or anagrelide in the last 24 hours.

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I have severe COPD with low oxygen levels.

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My blood cancer involves more than 10% of certain blood cells.

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I have not had major surgery within the last 2 weeks.

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I have not had a heart attack or severe heart failure in the last 6 months.

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I am on a blood thinner higher than 81mg aspirin or other types.

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I have had portal hypertension or related complications.

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I haven't had any cancer except for skin, prostate, or cervical cancer in the last 3 years.

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I have a condition or had surgery that affects how my body absorbs food.

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I have had a stem cell transplant before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess patients for any evidence of preliminary activity by determining the number of patients with ≥ 35% spleen volume reduction (SVR35)

Determine the incidence of dose-limiting toxicities (DLTs)

Determine the incidence of treatment emergent adverse events

Secondary study objectives

Determine the change in Patient Global Impression of Change (PGIC) at week 24 through end of study.

Determine the incidence of QT interval changes

Establish the Area under the plasma concentration versus time curve (AUC) of nuvisertib monotherapy, in combination with ruxolitinib, and in combination with momelotinib

+6 more

Other study objectives

Establish overall survival

Study potential pharmacodynamic (PD) markers of nuvisertib