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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the incidence of dose-limiting toxicities (DLTs) at escalated doses of TP-3654
Determine the incidence of treatment emergent adverse events
Secondary outcome measures
Assess patients for any evidence of Preliminary activity by proportion of patients with responses in complete remission, partial remission, clinical improvement, progressive disease and stable disease
Assess the reduction in bone marrow fibrosis in repeat biopsies
Determine Overall Survival
+9 moreOther outcome measures
Study potential pharmacodynamic (PD) markers of TP-3654
Trial Design
1Treatment groups
Experimental Treatment
Group I: TP-3654Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-3654
2019
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,548 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,869 Total Patients Enrolled
Sumitomo Pharma America, Inc.Lead Sponsor
237 Previous Clinical Trials
52,652 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to give bone marrow samples at the start and every 6 months during the study.My spleen is enlarged, confirmed by a doctor's exam or imaging tests.You have a peripheral blood blast count of less than 10%.I have tried a JAK inhibitor for my condition without success or cannot use Ruxolitinib or Fedratinib.My electrolyte levels are stable or can be corrected.I haven't had cancer treatment or experimental therapy in the last 14 days or 5 half-lives, whichever is longer.I have had my spleen removed or received spleen radiation in the last 6 months.I do not have any ongoing serious infections needing antibiotics in the last 2 weeks.I am eligible for a bone marrow or stem cell transplant within 3 months after joining.I do not have brain cancer, cancer spread to the brain, or any condition affecting my nervous system.I haven't taken more than 10 mg of steroids daily in the last week.I have taken hydroxyurea or anagrelide in the last 24 hours.I have severe COPD with low oxygen levels.My blood cancer involves more than 10% of certain blood cells.My kidney function is within the required range.I can take care of myself but might not be able to do heavy physical work.I have not had major surgery within the last 2 weeks.I have at least 2 symptoms of my condition that can be measured.I have not had a heart attack or severe heart failure in the last 6 months.My liver functions and blood clotting levels are within the required range.I have tried a JAK inhibitor for my condition and it didn't work or I can't take Ruxolitinib or Fedratinib.My recent tests show significant scarring in my bone marrow.I have been diagnosed with a type of myelofibrosis and it's considered intermediate or high-risk.I am on a blood thinner higher than 81mg aspirin or other types.I have had portal hypertension or related complications.I haven't had any cancer except for skin, prostate, or cervical cancer in the last 3 years.I have a condition or had surgery that affects how my body absorbs food.I do not have any ongoing, uncontrolled bleeding issues.I have had a stem cell transplant before.Platelet count ≥ 25 x 10^9/L, without the assistance of growth factors or platelet transfusions.My white blood cell count is healthy without needing medication to help.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: TP-3654
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate figure of participants in this experiment?
"This study necessitates the enrollment of 60 individuals who meet its inclusion requirements. Individuals can become a part of this trial at sites such as University of Virginia Cancer Center in Charlottesville, Virginia and The University of Arizona Cancer Center in Tucson, Arizona."
Answered by AI
What is the targeted outcome of this experiment?
"The chief aim of this 28-day medical trial is to gauge the occurrence of treatment-related side effects. Secondary objectives include ascertaining the peak plasma concentration (Cmax) level, determining any changes in QT interval and morphology using Holter ECG monitoring, and noting shifts in patient global impression of change (PGIC) scores at week 24."
Answered by AI
Is this project actively gathering participants?
"According to clinicaltrials.gov, recruitment of participants is still ongoing for this medical trial which was published on December 16th 2019 and updated as recently as May 26th 2022."
Answered by AI
How many venues are participating in this trial?
"Six centres are executing this clinical trial, including the University of Virginia Cancer Centre in Charlottesville, The University of Arizona Cancer Center in Tucson and Duke Cancer Institute in Durham. An additional three medical institutes across the United States are also participating."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
How old are they?
65+
What site did they apply to?
The University of Arizona Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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