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Alizapride

Clinical trials are studying Alizapride as part of cancer research in adults with solid tumours. The main goal is to see whether blood immune markers can help predict immune-related toxicities during checkpoint inhibitor treatment, while also tracking safety. This trial is a phase 2 interventional study.

Table of contents

Trial overview

The available trial on Alizapride is an interventional study, which means the research team is following people during a planned treatment setting and measuring outcomes over time.[1] It is a phase 2 trial and is listed as Authorised.[1] The study plans to enroll 441 participants.[1]

The main goal is to explore whether blood immune markers can help identify biomarkers for immune-related toxicities linked to checkpoint inhibitor treatment.[1] A biomarker is a measurable sign in the body that may help predict or track a disease or treatment effect.

Who is being studied

This trial includes cancer patients with a solid tumour.[1] A solid tumour is a cancer that forms a mass in an organ or tissue, rather than a blood cancer.

The source data do not provide more detailed inclusion or exclusion rules, so only the broad target population can be described from the trial record.[1]

What the researchers are measuring

The primary outcome is the change in immune blood markers, including serum autoantibody levels, at three time points during checkpoint inhibitor treatment: early, mid time, and late.[1] The same markers are also measured when immune-related adverse events occur.[1]

In simple terms, the team is checking whether blood tests change over time and whether those changes are linked to side effects from treatment.[1] This may help doctors in the future understand which patients are more likely to develop toxicity during immunotherapy.

Trial design and treatment context

The study is focused on checkpoint inhibitor therapy in cancer patients.[1] The intervention list contains many cancer medicines, including Alizapride, but the source data do not explain a direct treatment role for each listed drug within the study record.[1]

The brief summary says the study is a pilot project.[1] A pilot study is an early research project used to explore whether a larger idea is worth studying further.

Safety assessment

Safety will be assessed by investigators using reported adverse events and the CTCAE system, which stands for Common Terminology Criteria for Adverse Events.[1] This system is a standard way to describe and grade side effects in clinical trials.

The safety assessment is important because the study is looking at immune-related toxicities during checkpoint inhibitor treatment.[1] In this context, the researchers are not only looking for blood marker changes, but also checking how often and how severely side effects happen.

Key points for patients

  • The study is about cancer patients with solid tumours who are receiving checkpoint inhibitor treatment.[1]

  • The main research question is whether blood immune markers can help predict toxicity during treatment.[1]

  • Researchers are checking serum autoantibody levels at several points during treatment and when side effects appear.[1]

  • The trial is phase 2, authorised, and plans to include 441 people.[1]

  • Safety is tracked with reported adverse events using the CTCAE grading system.[1]

Trial ID Phase Condition studied Status Enrollment
2023-505360-11-00 Phase 2 Solid tumour Authorised 441

FAQ

  • What is being studied in the Alizapride trial? The trial is studying immune blood markers, including serum autoantibody levels, in people treated with checkpoint inhibitors. It looks for changes at different times during treatment and when immune-related side effects occur.
  • Who can take part in this trial? The trial is for cancer patients with a solid tumour. The data do not give more detailed entry rules in the source provided.
  • What phase is the Alizapride trial? This is a phase 2 trial. Phase 2 studies usually look more closely at how well a strategy works and continue to collect safety information.
  • What outcomes are the researchers measuring? They are measuring changes in immune blood markers at early, middle, and late time points during treatment, and also when immune-related adverse events happen. Safety is also assessed using reported adverse events.
  • Is this trial testing Alizapride alone? No. Alizapride is listed among several drugs used in the study context, while the main research focus is on immune markers and toxicity during checkpoint inhibitor treatment.

Ongoing Clinical Trials on Alizapride

  • Study on Immune Markers for Checkpoint Inhibitor Toxicity in Cancer Patients Using Atezolizumab, Dexamethasone Sodium Phosphate, and Alizapride

    Recruiting

    2 1 1 1
    Investigated drugs:
    Belgium

Glossary

  • Solid tumour: A cancer that forms a mass in an organ or tissue, such as in the lung, breast, or colon.
  • Interventional study: A clinical trial where researchers give a treatment or strategy and then measure the results.
  • Phase 2: A mid-stage trial that looks more closely at whether a research approach is useful and continues safety checks.
  • Checkpoint inhibitor: A type of cancer treatment that helps the immune system attack cancer cells. These drugs are central to this study.
  • Immune-related adverse event: A side effect caused by the immune system becoming too active or affecting healthy tissue during treatment.
  • Immune blood markers: Substances in the blood that can show how the immune system is behaving.
  • Serum autoantibody level: A blood test measure of autoantibodies, which are antibodies that react against the body's own tissues.
  • CTCAE: A standard system called Common Terminology Criteria for Adverse Events. It is used to grade and report side effects in trials.
  • Baseline: The starting point before treatment changes are measured.
  • Enrollment: The number of people planned or included in a study.

References

  1. https://clinicaltrials.gov/study/2023-505360-11-00