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INCB057643 +/- Ruxolitinib for Myelofibrosis (LIMBER Trial)
Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Primary MF or secondary MFs (post-PV MF, post-ET MF), histologically or cytologically confirmed according to WHO 2016 criteria.
- Primary MF or secondary MFs (post-PV MF, post-ET MF), histologically or cytologically confirmed according to WHO 2016 criteria with measurable disease and risk category of intermediate-2 or high according to DIPSS.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 9 months
Awards & highlights
LIMBER Trial Summary
This trial is testing a new drug, INCB057643, to see if it is safe and effective at treating myelofibrosis and other myeloid neoplasms either alone or in combination with another drug, ruxolitinib.
Who is the study for?
This trial is for adults with myelofibrosis or other advanced myeloid neoplasms who have tried at least one treatment without success. They must not be candidates for a stem-cell transplant and agree to prevent pregnancy. A palpable spleen of certain size and specific disease risk categories are required.Check my eligibility
What is being tested?
The study tests the safety and potential effectiveness of INCB057643 alone or combined with ruxolitinib in treating myelofibrosis and related conditions. Participants will either receive this new treatment option or continue their current dose of ruxolitinib if already on it.See study design
What are the potential side effects?
Possible side effects include reactions similar to those experienced with other cancer treatments, such as fatigue, digestive issues, blood disorders, increased infection risk, and any unique effects related to BET inhibitors which were previously intolerable.
LIMBER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is confirmed as primary or secondary myelofibrosis according to WHO 2016.
Select...
My condition is a type of myelofibrosis, confirmed by tests and considered high-risk.
Select...
I am 18 years old or older.
Select...
I am not eligible for treatments that could potentially cure my condition, like stem-cell transplantation.
Select...
My MDS is classified from very low to high risk according to IPSS-R.
Select...
I do not have juvenile myelomonocytic leukemia.
Select...
My condition is a relapse or resistant to treatment for myelofibrosis, MDS, or MDS/MPN.
Select...
My condition is a type of blood cancer classified as MDS/MPN according to WHO 2016.
Select...
My condition is a type of blood cancer that has returned or didn't respond to treatment.
Select...
My spleen is enlarged and can be felt more than 10 cm below my rib cage.
Select...
I have myelofibrosis and have been treated with a JAK inhibitor.
Select...
I am not eligible for treatments that could potentially cure my condition, like stem-cell transplantation.
LIMBER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment-emergent adverse events
Secondary outcome measures
Anemia Response (MF only)
BM Blast Partial Remission (MF, MDS, and MDS/MPN)
Bone Marrow (BM) Blast Complete Remission (MF, myelodysplastic syndrome (MDS), and MDS/myeloproliferative neoplasm (MPN))
+11 moreLIMBER Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2 : INCB057643 Combination with RuxolitinibExperimental Treatment2 Interventions
Combination arm in dose escalation and dose expansion
Group II: Part 1 : INCB057643 MonotherapyExperimental Treatment1 Intervention
INCB057643 dose escalation and dose expansion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
365 Previous Clinical Trials
55,079 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to have a bone marrow test before treatment starts.I have previously taken a BET inhibitor and stopped due to side effects.My condition is confirmed as primary or secondary myelofibrosis according to WHO 2016.I am part of the dose escalation and expansion phase for myelofibrosis treatment.My condition is a type of myelofibrosis, confirmed by tests and considered high-risk.I had a stem cell transplant from a donor within the last 6 months.I am not on any other cancer treatments.I have been on a stable dose of ruxolitinib alone for at least 8 weeks.You agree not to get pregnant or father children during the study.I am currently taking ruxolitinib and can continue without stopping.I am 18 years old or older.I am willing to have a bone marrow test before treatment starts.I have an active hepatitis B or C infection, or I'm at risk for hepatitis B reactivation.I've had treatment before, it didn't work or I couldn't tolerate it, and there's no other known beneficial treatment.I am not eligible for treatments that could potentially cure my condition, like stem-cell transplantation.My MDS is classified from very low to high risk according to IPSS-R.My spleen is enlarged and can be felt at least 5 cm below my ribcage.I do not have juvenile myelomonocytic leukemia.My condition is a relapse or resistant to treatment for myelofibrosis, MDS, or MDS/MPN.I have received treatment before.My condition is a type of blood cancer classified as MDS/MPN according to WHO 2016.My condition is a type of blood cancer that has returned or didn't respond to treatment.My condition is a specific type of disease.My spleen is enlarged and can be felt more than 10 cm below my rib cage.I have myelofibrosis and have been treated with a JAK inhibitor.My condition is...I am not eligible for treatments that could potentially cure my condition, like stem-cell transplantation.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 : INCB057643 Combination with Ruxolitinib
- Group 2: Part 1 : INCB057643 Monotherapy
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.
Is this research still recruiting participants?
"Indeed, the clinicaltrials.gov webpage indicates that this trial is still in progress and recruiting patients. It was initiated on February 23rd 2021 and its most recent changes were made on October 17th 2022; the study requires 39 participants to be recruited from 12 different medical centres."
Answered by AI
What potential side effects should patients be aware of when taking INCB057643?
"Due to limited information regarding INCB057643's safety and efficacy, our team at Power assigns it a score of 1 on the scale from 1-3."
Answered by AI
In how many areas is this investigation being conducted?
"To date, 12 clinical trial sites are enrolling patients for this medical study. These include the University of Colorado Cancer Center in Aurora, University of North carolina At Chapel Hill in Chapel Hill and Seattle Cancer Care Alliance in Seattle plus other locations."
Answered by AI
What is the current survey size for this experiment?
"Affirmative. According to clinicaltrials.gov, this research endeavour has been actively recruiting since its initial posting on February 23rd 2021 and is currently searching for 39 participants from 12 sites."
Answered by AI
Are there any recorded precedents of investigations involving INCB057643?
"The National Institutes of Health Clinical Center's 9000 Rockville Pike location was where INCB057643 received its first scientific investigation in 2002. Presently, 97 trials are actively recruiting participants with Aurora, North carolina housing a large portion of them; 93 studies have been completed to date."
Answered by AI
What medical conditions can be managed through the use of INCB057643?
"INCB057643 is most commonly prescribed to patients with polycythemia vera. Additionally, this medication can be effective for treating other diseases such as refractory/intolerant hydroxyurea-associated polycythaemia and primary myelofibrosis."
Answered by AI
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