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Study for Patients with Advanced Malignancies: Continued Treatment with Parsaclisib Alone or with Itacitinib, Ruxolitinib, Ibrutinib, or Tafasitamab

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for people with advanced cancers and certain immune system diseases. The study involves a medication called parsaclisib, which is being tested either on its own or in combination with other treatments. These additional treatments include itacitinib, ruxolitinib, ibrutinib, and tafasitamab. The purpose of the study is to continue providing treatment and to monitor the safety of these medications in participants who have been part of previous studies involving parsaclisib.

Participants in this study will continue to receive their treatment as they have been, and the study will observe how they respond to the medication over time. The study will not introduce any new treatments but will focus on maintaining the current treatment regimen. The study aims to ensure that participants continue to benefit from the treatment and to gather information on any side effects they may experience.

The study is designed to be open-label, meaning that both the participants and the researchers know which treatments are being administered. This approach helps in closely monitoring the effects of the treatment and ensuring the safety of the participants. The study will continue until the estimated end date, allowing researchers to collect comprehensive data on the long-term effects and safety of the treatments being studied.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment in the study

    Upon joining the study, you will continue the treatment you were receiving in a previous clinical study involving parsaclisib.

    Your participation is based on your current tolerance and benefit from the treatment as determined by the study investigator.

  2. Step 2

    Treatment continuation

    You will receive parsaclisib either alone or in combination with other medications such as itacitinib, ruxolitinib, ibrutinib, or tafasitamab.

    The form of parsaclisib is a tablet taken orally.

  3. Step 3

    Medication administration

    If you are taking ruxolitinib, it will be in the form of Jakavi 5 mg tablets for oral use.

    If you are taking ibrutinib, it will be in the form of IMBRUVICA 140 mg hard capsules for oral use.

    If you are taking tafasitamab, it will be administered as an intravenous infusion using MINJUVI 200 mg powder for concentrate for solution for infusion.

  4. Step 4

    Safety evaluation

    Throughout the study, your safety will be closely monitored to assess any adverse effects or serious adverse effects from the treatment.

    Regular check-ups and assessments will be conducted to ensure your well-being.

  5. Step 5

    Study duration

    The study is expected to continue until September 30, 2024.

    Your participation will involve regular visits and adherence to the treatment plan as outlined in the study protocol.

Who can join the trial?

8 criteria

  • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
  • Currently tolerating treatment in the parent Protocol.
  • Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone) as determined by the investigator.
  • Has at least stable disease, as determined by the investigator.
  • Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis (a preventive treatment for a type of lung infection), and any other study procedures indicated in this Protocol.
  • Willingness to avoid pregnancy or fathering children based on the criteria described in Protocol section 5.1.
  • Ability to comprehend and willingness to sign an ICF (Informed Consent Form).

Who cannot join the trial?

2 criteria

  • Patients with **advanced malignancies** (serious forms of cancer) cannot participate.
  • Patients with **IAI diseases** (immune system-related diseases) are not eligible.
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Investigated drugs

  • Parsaclisib

    is a medication being studied for its ability to help treat certain types of cancer. It works by blocking specific proteins in the body that help cancer cells grow. In this trial, participants who were already taking Parsaclisib in previous studies can continue their treatment to see if it remains safe and effective over a longer period.

  • Itacitinib

    is another medication involved in this trial. It is used to help manage conditions related to the immune system. Itacitinib works by interfering with certain signals in the body that can cause inflammation and other immune responses. In this study, it is being used in combination with Parsaclisib to see if the two medications together can provide better results for patients.

  • Ruxolitinib

    is a medication that helps reduce inflammation and is often used to treat certain blood disorders. It works by blocking specific enzymes in the body that contribute to inflammation and abnormal blood cell production. In this trial, Ruxolitinib is being combined with Parsaclisib to evaluate if this combination can improve treatment outcomes for patients.

  • Ibrutinib

    is a medication that targets certain proteins in cancer cells, helping to slow down or stop their growth. It is commonly used to treat various types of blood cancers. In this study, Ibrutinib is being used alongside Parsaclisib to determine if the combination is more effective than using either medication alone.

  • Tafasitamab

    is a medication that helps the immune system recognize and attack cancer cells. It is often used in the treatment of certain types of lymphoma. In this trial, Tafasitamab is being used both in combination with Parsaclisib and on its own to see how well it works in treating patients who have been part of previous studies.

What is already known about the treatment

  • Parsaclisib

    Parsaclisib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced cancers and certain immune-related diseases. It is an investigational drug, meaning it is still being researched and is not yet widely available in medical practice. Parsaclisib works by inhibiting specific enzymes in the body that are involved in the growth and survival of cancer cells, helping to slow down or stop their progression. It belongs to a class of drugs known as PI3K inhibitors, which target pathways that are often overactive in cancer cells.

  • Itacitinib

    Itacitinib is taken orally and is being evaluated in clinical trials for its potential to treat advanced cancers and immune-related conditions. It is not yet approved for general medical use and is still under investigation. Itacitinib functions by blocking certain proteins in the body that contribute to inflammation and cancer cell growth, thereby potentially reducing disease symptoms and progression. It is classified as a JAK inhibitor, which targets specific pathways involved in immune response and cell growth.

  • Ruxolitinib

    Ruxolitinib is an oral medication currently being studied in combination with other drugs for its role in treating advanced cancers and immune-related diseases. While it is already approved for some conditions, its use in these specific trials is still under investigation. Ruxolitinib works by inhibiting enzymes known as Janus kinases, which play a role in the signaling pathways that regulate immune function and cell growth. It is part of the JAK inhibitor class of medications.

  • Ibrutinib

    Ibrutinib is administered orally and is being tested in clinical trials for its effectiveness in combination therapies for advanced cancers and immune-related diseases. It is already approved for certain types of cancer, but its use in these trials is still being explored. Ibrutinib acts by blocking a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancer cells. It is classified as a BTK inhibitor, targeting pathways that are crucial for cancer cell proliferation.

  • Tafasitamab

    Tafasitamab is given as an intravenous infusion and is being studied in clinical trials for its potential use in combination with other drugs to treat advanced cancers and immune-related diseases. It is an investigational drug in these trials, although it is approved for certain conditions. Tafasitamab works by targeting a specific protein on the surface of cancer cells, marking them for destruction by the immune system. It belongs to a class of drugs known as monoclonal antibodies, which are designed to recognize and bind to specific proteins on cells.

Investigated diseases

  • Advanced Malignancies

    Advanced malignancies refer to cancers that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These malignancies can affect various organs and tissues, leading to a range of symptoms depending on the location and extent of the spread. As the disease progresses, it may cause significant changes in bodily functions and overall health. The progression can vary greatly depending on the type of cancer and individual patient factors. Advanced malignancies often require complex management due to their widespread impact on the body. The disease can lead to a decline in physical abilities and quality of life as it advances.

  • Idiopathic Autoimmune Diseases

    Idiopathic autoimmune diseases are conditions where the immune system mistakenly attacks the body's own tissues, and the exact cause of this immune response is unknown. These diseases can affect various parts of the body, leading to inflammation and damage to healthy tissues. The progression of idiopathic autoimmune diseases can vary widely, with some individuals experiencing mild symptoms and others facing severe complications. Over time, these diseases can lead to chronic pain, fatigue, and organ dysfunction. The course of the disease is often unpredictable, with periods of remission and flare-ups. As the disease progresses, it can significantly impact daily life and overall well-being.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501687-18-00Protocol codeINCB 50465-801Estimated enrolment200 patientsSponsorIncyte Corp.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).