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INCA033989 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
Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years and 60 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called INCA033989 in patients with a type of blood cancer. The goal is to find the safest and most effective dose by checking for side effects and how well the drug works.
Who is the study for?
This trial is for people who have been diagnosed with myeloproliferative neoplasms, specifically Myelofibrosis (MF) or Essential Thrombocythemia (ET), and are expected to live more than 6 months. They must be willing to undergo bone marrow biopsies and have a documented CALR exon-9 mutation.
What is being tested?
The study tests INCA033989's safety and tolerability in patients with myeloproliferative disorders. It aims to find the highest dose patients can take without serious side effects (MTD) and suggest doses for future studies.
What are the potential side effects?
Possible side effects of INCA033989 include reactions at the drug administration site, fatigue, changes in blood counts, gastrointestinal symptoms, liver enzyme alterations, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show a CALR exon-9 mutation.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 1b: Dose Expansion - with MFExperimental Treatment1 Intervention
INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
Group II: Part 1b: Dose Expansion - with ETExperimental Treatment1 Intervention
INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
Group III: 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 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 IV: 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 to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with essential thrombocythemia (ET) will enroll in this group.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myeloproliferative Neoplasms (MPNs) include targeted therapies like JAK inhibitors (e.g., ruxolitinib and fedratinib) and novel agents that modulate blood cell proliferation. JAK inhibitors work by blocking the Janus kinase (JAK) pathway, which is often overactive in MPNs, leading to uncontrolled cell growth.
By inhibiting this pathway, these drugs help reduce symptoms such as splenomegaly and improve overall quality of life. Novel agents like INCA033989, currently under study, aim to further refine this approach by targeting specific molecular mechanisms involved in MPNs.
These treatments are vital for MPN patients as they offer more precise control over disease progression and symptom management, potentially leading to better outcomes and fewer side effects compared to traditional therapies.
Recent advances in diagnosis and treatment of chronic myeloproliferative neoplasms.
Recent advances in diagnosis and treatment of chronic myeloproliferative neoplasms.
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
393 Previous Clinical Trials
63,826 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
34 Previous Clinical Trials
12,129 Total Patients Enrolled