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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

LIMBER Trial Summary

This trial tests the safety, dose and effects of a new drug for people with a blood cancer.

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.Check my eligibility

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.See study design

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.

LIMBER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My tests show a CALR exon-9 mutation.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years and 60 days for reporting.

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 more

LIMBER 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

365 Previous Clinical Trials

55,155 Total Patients Enrolled

Incyte Medical MonitorStudy DirectorIncyte Corporation

23 Previous Clinical Trials

4,932 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous healthcare facilities in Canada actively participating in this experiment?

"Patients can elect to receive treatment in Moffitt Cancer Center (Tampa), The University of Kansas Cancer Center (Westwood) or Stanford Cancer Institute (Palo Alto). Furthermore, there are 10 additional sites where patients may seek care."

Answered by AI

What are the goals of this research endeavor?

"The main outcome of this clinical trial, assessed up to 28 days after initiating treatment, is the number of patients who experience Treatment-emergent Adverse Events (TEAEs). Additionally, secondary objectives involve examining participants' Pharmacokinetics Parameter: Vz/F with INCA33989; gauging Mean change in disease-related allele burden through targeted NGS and measuring myeloid and lymphoid proportions in blood; as well as determining Participants With ET: Response Rate from those receiving Complete or Partial Responses."

Answered by AI

What risks have been associated with the Part 1b: Dose Expansion - with ET protocol?

"Our team at Power assigned Part 1b: Dose Expansion - with ET a score of 1, as it is currently in Phase 1 and has not yet accumulated sufficient clinical data to demonstrate its efficacy or safety."

Answered by AI

How many people are taking part in this clinical research?

"To complete the trial, Incyte Corporation must enroll 140 qualified patients from various locations. These include Moffitt Cancer Center in Tampa, Florida as well as The University of Kansas Cancer Center in Westwood, Kansas."

Answered by AI

Are researchers still enrolling participants for this clinical trial?

"This clinical trial is actively enrolling participants. The protocol was first made available on December 7th 2023 and has since been updated most recently on November 16th of the same year, according to information posted on clinicaltrials.gov"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

2023. "A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034002.

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