218 Participants NeededMy employer runs this trial

INCA036978 for Myeloproliferative Disorder

Recruiting at 54 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called INCA036978 for individuals with certain myeloproliferative disorders, such as myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET). The trial aims to assess the treatment's safety, its effects on the body, and the optimal dose when used alone or with standard therapies. Suitable candidates for this trial include those diagnosed with MF, PV, or ET who have a life expectancy of more than six months. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that you cannot have treatment with an MPN-directed therapy (approved or investigational) within a certain time before starting the study drug.

Is there any evidence suggesting that INCA036978 is likely to be safe for humans?

Research is testing INCA036978 to determine its safety when used alone or with other treatments. So far, studies have focused on identifying the right dose that minimizes side effects.

Prospective participants should know this is an early-stage study. The primary goal is to assess the treatment's safety and tolerability. Researchers closely monitor any side effects that might limit the dose.

Specific safety results are not yet available, as this early-stage trial is just beginning to gather that information. This trial is a crucial step to ensure the treatment's safety before further testing.12345

Why do researchers think this study treatment might be promising for myeloproliferative disorder?

Researchers are excited about INCA036978 because it represents a novel approach to treating myeloproliferative disorders. Unlike current standard treatments, which often involve medications like hydroxyurea or interferon, INCA036978 is being explored for its unique mechanism of action. This drug is designed to be used both as a monotherapy and in combination with existing therapies, potentially enhancing treatment effectiveness and patient outcomes. By focusing on finding the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE), researchers aim to optimize its therapeutic impact while minimizing side effects.

What evidence suggests that INCA036978 might be an effective treatment for myeloproliferative disorder?

Research has shown that INCA036978 is designed to treat myeloproliferative disorders by targeting specific parts of the disease process. In this trial, participants will receive INCA036978 either as a monotherapy or in combination with standard treatments. Early studies are examining the drug's safety and determining the optimal dose when used alone. When combined with standard treatments, researchers are evaluating its impact on patient outcomes. The goal is to identify the highest safe dose while monitoring its effectiveness in reducing symptoms like an enlarged spleen and improving low red blood cell counts (anemia). Although data collection on its effectiveness continues, this approach shows promise by directly targeting the disease.24567

Who Is on the Research Team?

IM

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for people diagnosed with certain blood disorders called myeloproliferative neoplasms, including myelofibrosis, polycythemia vera, and essential thrombocythemia. Participants should have a life expectancy over 6 months and be willing to undergo bone marrow tests.

Inclusion Criteria

* Life expectancy \> 6 months.
I am willing to have bone marrow biopsies before and during the study.
I have been diagnosed with MF, PV, or ET.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INCA036978 is administered at a protocol-defined starting regimen to identify the maximum tolerated dose and/or recommended dose for expansion

Up to 28 days

Dose Expansion

INCA036978 is administered as monotherapy and in combination with a standard disease-directed therapy at the recommended dose for expansion

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

  • INCA036978

Trial Overview

The study is testing a new drug called INCA036978 alone or together with standard treatments for these blood disorders. The main goal is to find the safest dose and check how well patients tolerate it.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Part 2b: Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 2a: Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1b: Dose EscalationExperimental Treatment2 Interventions
Group IV: Part 1a: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1.

ucla.clinicaltrials.researcherprofiles.org

ucla.clinicaltrials.researcherprofiles.org/trial/NCT07441694

INCA036978 in Participants With Myeloproliferative Neoplasms

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose ...

Study of INCA036978 in Participants With... | Clinical Trial

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose...

A drug, INCA036978, alone and in combination with ...

To find out:The highest dose of INCA036978 that's safe to giveIf INCA036978 is safe and works well to treat MPN.

INCA036978 for Myeloproliferative Disorder

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose ...

Study of INCA036978 in Participants With ...

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose…

Safety and Tolerability of INCA036978 in Myeloproliferative ...

This is a Phase 1 study focusing on a drug called INCA036978. The study aims to understand the safety and tolerability of this drug when used alone and in ...

Study of INCA036978 in Participants With Myeloproliferative ...

This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or ...