Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Trial ID: NCT04279847

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy for participants with relapsed or refractory myelofibrosis (MF), myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN).

Trial Details

The purpose of this Study is to test the safety and efficacy of a Study Drug called INCB057643 and to find out what effects the study drug has on people with myelofibrosis. This is an open-label study, which means that both you and your study doctor will know what you are receiving. You will be in this Study for about 9 months, during which time you cannot participate in other research studies.

Estimated Enrollment

39 Participants

Phase

1

Eligibility Criteria

Participants must:

Relapsed or refractory PMF, PPV-MF, or PET-MF
Part 1 and Part 2, Treatment Group A:
- Have received ≥ 1 line of prior therapy and have no further available therapy known to provide clinical benefit
- Participants with MF must have received JAK inhibitor(s) such as ruxolitinib
Part 2, Treatment Group B:
- Must have currently been treated with ruxolitinib monotherapy at a stable dose for ≥ 8weks.

Participants must not:

Prior treatment with any BET inhibitor
History of bleeding disorder or at high risk of bleeding
Have received HSCT within 6 months of enrollment or have active GVHD, or have received immunosuppressive therapy following HSCT within 2 weeks of treatment start

What Will Happen in This Study?

Sites are located in the cities/states identified with the red pin:

What’s Involved

You will need to visit a study clinic. A study doctor will provide you with an informed consent and explain the trial. You will then be fully evaluated for participation and eligibility. If eligible, you will be enrolled in the study. The study will last for approximately 2 years, and include regular, scheduled visits to the clinical study center. During these visits, you will undergo a physical exam and have blood work performed. A scan (MRI or CT) will be performed about every 6 months during your study participation. Once the study has completed, if you are benefitting from treatment, you will have the option to continue the treatment. Full details about study treatment, clinic visit schedule and exams will be discussed with you prior to any enrollment.

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

Some trials pay for the participants’ travel costs, time and commitment. Not all do. The amount paid varies. You should read the informed consent and ask the study doctor for this information for a specific clinical trial.

What is a placebo?

A placebo looks like a treatment but does not have any real treatment. In clinical trials, investigational treatments are often compared with placebos. Some participants are given a placebo instead of a treatment. This helps make sure that any effects are actually caused by the treatment being studied.

How can I check to see if I'm eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new vaccines or treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements. If you decide to stop study treatment, we will still ask you to come back to the hospital or clinic to have an end of treatment visit within 7 days of terminating the treatment and an end of study visit 4 weeks later.

This trial is not actively recruiting.