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Monoclonal Antibodies
INCA033989 + Ruxolitinib for Myeloproliferative Disorder (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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years and 60 days
Awards & highlights
LIMBER Trial Summary
This trial is testing a new drug for a blood cancer, to see how safe and effective it is.
Who is the study for?
This trial is for people with myeloproliferative neoplasms who have a life expectancy over 6 months and measurable disease. They must be in good enough health to perform daily activities (ECOG score of 0-2) and willing to undergo bone marrow procedures. Participants should not have other active cancers, significant heart issues, or certain infections like HIV.Check my eligibility
What is being tested?
The study tests INCA033989 alone or combined with Ruxolitinib to find the safest and most effective doses for treating myeloproliferative neoplasms. It aims to identify any dose-related toxicities and establish recommended dosages for further research.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include fatigue, digestive problems, blood count changes, potential liver function alterations, and reactions at the infusion site. The severity can range from mild discomforts to more serious complications.
LIMBER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years and 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years and 60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Mean change in disease-related allele burden
Participants With ET: Mean change from baseline of total symptom score (TSS)
Participants With ET: Response Rate
+11 moreLIMBER Trial Design
7Treatment groups
Experimental Treatment
Group I: Part 1c: Dose ExpansionExperimental Treatment2 Interventions
INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.
Group II: Part 1b: Dose Expansion - with TGB-MF SubOpt RExperimental Treatment2 Interventions
INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.
Group III: Part 1b: Dose Expansion - with MFExperimental Treatment1 Intervention
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
Group IV: Part 1b: Dose Expansion - with ETExperimental Treatment1 Intervention
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
Group V: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt RExperimental Treatment2 Interventions
INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.
Group VI: Part 1a Dose Escalation Cohort Disease Group A - with MFExperimental Treatment1 Intervention
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group.
Group VII: Part 1a Dose Escalation Cohort Disease Group A - with ETExperimental Treatment1 Intervention
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with with essential thrombocythemia (ET) will enroll in this group.
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
55,070 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
23 Previous Clinical Trials
4,847 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have blood cancer, except for ET, PMF, or post-ET MF.I have had an active cancer within the last 2 years.I have a serious heart condition that is not under control.I have been diagnosed with myelofibrosis or essential thrombocythemia.My tests show a CALR exon-9 mutation.I have had or am planning to have a stem-cell transplant.I haven't taken G-CSF, GM-CSF, romiplostim, or eltrombopag in the last 4 weeks.I am not taking strong drugs that affect liver enzymes within 14 days before starting the study.I am willing to have bone marrow tests before and during the study.I haven't taken any cancer treatments within the last 28 days or 5 half-lives, whichever is shorter.I have not had major bleeding or blood clots in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1c: Dose Expansion
- Group 2: Part 1b: Dose Expansion - with ET
- Group 3: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R
- Group 4: Part 1b: Dose Expansion - with TGB-MF SubOpt R
- Group 5: Part 1a Dose Escalation Cohort Disease Group A - with MF
- Group 6: Part 1a Dose Escalation Cohort Disease Group A - with ET
- Group 7: Part 1b: Dose Expansion - with MF
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.
How many volunteers are currently enrolled in this experiment?
"Affirmative. Clinicaltrials.gov records note that this research is actively recruiting participants, with 225 individuals needed at 23 different sites since its posting on June 30th 2023 and latest update on the same date."
Answered by AI
Are researchers currently enrolling individuals into this clinical trial?
"Yes, clinicaltrials.gov has this trial noted as open for recruitment. The first posting was on June 30th 2023 and the most recent update to the listing occurred on that same date."
Answered by AI
What safety measures are in place for individuals participating in Part 1a Dose Escalation Cohort Disease Group A - with MF?
"Due to a lack of evidence backing the safety and efficacy of Part 1a Dose Escalation Cohort Disease Group A - with MF, our team at Power assigned it an interim score of 1."
Answered by AI
Are there any hospitals within the state that are currently pursuing this research?
"As of now, this study is recruiting patients in 23 different sites. Popular cities like Adelaide, Melbourne and Toronto can be found on the list as well other 20+ locations. To reduce travel costs, it would be beneficial to select a site that's proximal to your living area if you decide to participate."
Answered by AI
What are the key aims of this investigation?
"The primary goal of this clinical trial over the course of 28 days is to determine how many participants experienced Treatment-emergent Adverse Events (TEAEs). Secondary endpoints will include assessing percentage reduction in spleen volume - SVR35 and SVR25, as well as whether patients with symptomatic anemia had a response after 24 weeks of treatment."
Answered by AI
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