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Parsaclisib Hydrochloride

This article discusses a Phase 2 clinical trial investigating the continued use of Parsaclisib Hydrochloride, also known as INCB050465, for patients with advanced malignancies and immune-related diseases. The study aims to provide ongoing treatment for participants who have previously been enrolled in studies involving Parsaclisib, either as a standalone therapy or in combination with other drugs. The trial focuses on evaluating the safety and effectiveness of this treatment approach for patients who have shown clinical benefits from previous Parsaclisib studies.

Table of Contents

What is Parsaclisib?

Parsaclisib Hydrochloride, also known by its research code INCB050465, is a promising new medication being studied for the treatment of various advanced malignancies (cancers) and autoimmune diseases[1]. It is currently being developed by Incyte Corporation and is in the clinical trial phase, which means it’s still being tested to ensure its safety and effectiveness before it becomes widely available to patients.

Medical Conditions Treated

Parsaclisib is being investigated for its potential to treat two main categories of diseases:

  • Advanced malignancies: These are cancers that have progressed to an advanced stage[1].
  • IAI diseases: This likely refers to inflammatory and autoimmune diseases. One specific condition mentioned in the trial information is autoimmune hemolytic anemia, a disorder where the immune system mistakenly destroys red blood cells[1].

How Parsaclisib Works

While the exact mechanism of action is not detailed in the provided information, Parsaclisib is likely a targeted therapy. Many new cancer and autoimmune disease treatments work by targeting specific molecules involved in the disease process. This targeted approach often results in more effective treatment with fewer side effects compared to traditional therapies[1].

Administration and Dosage

Parsaclisib is administered as a tablet for oral use. The maximum daily dose being studied is 20 mg, with a maximum total dose of 13,990 mg over a treatment period of up to 23 months[1]. However, it’s important to note that these dosages are part of the clinical trial and may not reflect the final recommended dosage if the drug is approved for general use.

Current Clinical Trials

Parsaclisib is currently being studied in a Phase 2, open-label, multicenter rollover study. This study aims to provide continued treatment for participants who were previously enrolled in other studies of Parsaclisib and are experiencing clinical benefits[1]. The main objective of this study is to continue evaluating the safety of Parsaclisib when used alone or in combination with other medications such as itacitinib, ruxolitinib, ibrutinib, or tafasitamab.

Eligibility for Treatment

To be eligible for the current clinical trial, patients must meet several criteria, including:

  • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of Parsaclisib
  • Tolerating the treatment well
  • Experiencing clinical benefit from the treatment
  • Having at least stable disease, as determined by the investigator
  • Demonstrating compliance with the study requirements
  • Willingness to comply with scheduled visits and treatment plans[1]

Safety Monitoring

The primary focus of the current clinical trial is to assess the safety of Parsaclisib. Researchers are closely monitoring for adverse events (AEs) and serious adverse events (SAEs) in participants receiving Parsaclisib, either alone or in combination with other medications[1]. This ongoing safety evaluation is crucial for determining the long-term safety profile of the drug and identifying any potential risks or side effects.

It’s important to remember that Parsaclisib is still an investigational drug. While it shows promise, more research is needed to fully understand its effectiveness and safety profile. Patients interested in this treatment should discuss it with their healthcare provider to determine if participating in a clinical trial might be appropriate for their specific situation.

Aspect Details
Study Type Phase 2, Open-Label, Multicenter, Rollover Study
Main Objective Provide continued treatment and evaluate safety of Parsaclisib
Target Conditions Advanced malignancies and IAI diseases
Primary Medication Parsaclisib Hydrochloride (INCB050465)
Combination Therapies Itacitinib, Ruxolitinib, Ibrutinib, or Tafasitamab
Administration Route Oral use
Maximum Daily Dose 20 mg
Maximum Treatment Period 23 months
Primary Endpoint Assessment of AEs and SAEs
Key Eligibility Criteria Currently enrolled in Parsaclisib study, tolerating treatment, receiving clinical benefit

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to provide continued treatment and evaluate the safety of Parsaclisib (INCB050465) for participants who have previously been enrolled in studies using this drug. The trial aims to assess the drug's effectiveness as a monotherapy or in combination with other medications for patients with advanced malignancies and immune-related diseases.
  • Who is eligible to participate in this clinical trial? Eligible participants are those who are currently enrolled and receiving treatment in an Incyte-sponsored clinical study of Parsaclisib. They must be tolerating the treatment well, experiencing clinical benefits, and have at least stable disease as determined by the investigator. Additionally, participants must be willing to comply with scheduled visits, treatment plans, and study procedures.
  • What medications are being studied in this trial? The primary medication being studied is Parsaclisib (INCB050465). It may be used alone or in combination with other drugs such as itacitinib, ruxolitinib, ibrutinib, or tafasitamab. Some participants may remain on tafasitamab alone.
  • How long does the treatment period last? The maximum treatment period for this clinical trial is 23 months, as indicated in the drug information provided.
  • What are the main outcomes being measured in this study? The primary outcome being measured is the assessment of adverse events (AEs) and serious adverse events (SAEs) reported by participants receiving Parsaclisib as monotherapy or in combination with other drugs. This helps evaluate the safety profile of the treatment.

Ongoing Clinical Trials on Parsaclisib Hydrochloride

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

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Belgium Czechia Denmark France Italy Poland +2

Glossary

  • Advanced malignancies: Cancers that have spread beyond their original site or are at a late stage of development.
  • IAI diseases: Immune-mediated Autoinflammatory and Inflammatory diseases, which are conditions where the immune system mistakenly attacks the body's own tissues.
  • Monotherapy: Treatment using a single drug or therapeutic approach.
  • Phase 2 clinical trial: A stage of drug testing in humans that aims to evaluate the effectiveness and further study the safety of a new treatment in a larger group of people.
  • Rollover study: A type of clinical trial where participants from a previous study are enrolled to continue receiving treatment and follow-up.
  • Parsaclisib Hydrochloride: The active substance in the drug being studied, also known as INCB050465.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, cause persistent or significant disability, or lead to birth defects.
  • PJP prophylaxis: Preventive treatment to protect against Pneumocystis jirovecii pneumonia, a type of lung infection that can occur in people with weakened immune systems.
  • Stable disease: A condition in which a disease, such as cancer, is not getting worse or better, but remains relatively unchanged.

References

  1. http://clinicaltrials.eu/trial/study-for-patients-with-advanced-malignancies-continued-treatment-with-parsaclisib-alone-or-with-itacitinib-ruxolitinib-ibrutinib-or-tafasitamab/