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Taminadenant

Taminadenant, also known as NIR178, is an investigational drug being studied in clinical trials for patients with various types of advanced cancer. This article explores the ongoing research into Taminadenant’s safety and tolerability, as well as its potential benefits for cancer patients who have participated in previous Novartis-sponsored studies.

Table of Contents

What is TAMINADENANT?

TAMINADENANT is an investigational drug being developed by Novartis Pharma AG for the treatment of various types of advanced cancer[1]. It is also known by its product code NIR178[1]. This medication is currently being studied in clinical trials to evaluate its safety and effectiveness in cancer patients.

Medical Conditions Treated

TAMINADENANT is being investigated for the treatment of different types of advanced cancer[1]. Advanced cancer refers to cancer that has spread from its original site to other parts of the body or has grown significantly and is difficult to treat with standard therapies. The specific types of cancer being targeted in the clinical trials are not specified in the provided information.

Drug Administration

TAMINADENANT is administered as a hard capsule for oral use[1]. This means patients can take the medication by mouth, which is generally more convenient than other forms of cancer treatments like intravenous infusions. The maximum daily dose being studied is 480 mg[1]. The treatment period can last up to 533 days (approximately 1.5 years)[1], although this may vary depending on the patient’s response and the specific clinical trial protocol.

Clinical Trials and Safety

TAMINADENANT is currently being evaluated in clinical trials to assess its safety and effectiveness. The primary focus of these trials is to collect data on the safety and tolerability of the drug when used alone or in combination with other treatments[1]. Researchers are particularly interested in:

  • The frequency and nature of adverse events (AEs) and serious adverse events (SAEs)
  • The number of patients requiring dose interruptions or reductions
  • The duration of exposure to the drug

This information helps researchers and doctors understand how well patients can tolerate the medication and what side effects they might experience.

Eligibility for Treatment

To be eligible for treatment with TAMINADENANT in these clinical trials, patients typically need to meet certain criteria[1]:

  • They must be currently enrolled in a pre-defined Novartis-sponsored study involving TAMINADENANT
  • They should be receiving clinical benefit from the treatment, as determined by their doctor
  • They must have demonstrated compliance with the previous study’s requirements
  • They must be willing and able to comply with scheduled visits and treatment plans

It’s important to note that eligibility criteria may vary between different clinical trials, and a healthcare professional should be consulted for specific information.

Potential Benefits

While the full benefits of TAMINADENANT are still being studied, the ongoing clinical trials suggest that it may offer potential advantages for patients with advanced cancer[1]. Some possible benefits include:

  • A new treatment option for patients who may have limited alternatives
  • Oral administration, which can be more convenient than other cancer treatments
  • Potential for use alone or in combination with other cancer therapies
  • Continued access to the drug for patients who have shown benefit in previous trials

It’s important to remember that as an investigational drug, the full efficacy and safety profile of TAMINADENANT is still being determined through clinical trials. Patients should discuss the potential risks and benefits with their healthcare provider to make informed decisions about their treatment options.

Aspect Details
Drug Name Taminadenant (NIR178)
Study Type Open-label, multi-center rollover protocol
Target Population Patients with different types of advanced cancer
Main Objective Collect safety and tolerability data for Taminadenant
Secondary Objective Provide continued access to study treatment
Administration Oral use, hard capsules
Maximum Daily Dose 480 mg
Maximum Treatment Period 533 days
Primary Endpoint Frequency and nature of adverse events and serious adverse events
Secondary Endpoint Number of subjects receiving treatment and duration of exposure

FAQ

  • What is Taminadenant? Taminadenant, also known as NIR178, is an investigational drug being studied for the treatment of various types of advanced cancer. It is administered orally in the form of hard capsules.
  • What is the main goal of the clinical trial involving Taminadenant? The main objective of the trial is to collect safety and tolerability data for Taminadenant, either as a single agent or in combination with other study treatments. It also aims to provide continued access to the drug for patients who have participated in previous Novartis-sponsored studies.
  • Who is eligible to participate in this clinical trial? Eligible participants are those currently enrolled in a pre-defined Novartis-sponsored study and receiving Taminadenant. They must be deriving clinical benefit from the treatment and have demonstrated compliance with the parent protocol requirements.
  • What is the maximum daily dose of Taminadenant in the trial? The maximum daily dose of Taminadenant in the trial is 480 mg.
  • How long can patients receive treatment in this trial? The maximum treatment period for patients in this trial is 533 days, which is approximately 1.5 years.

Ongoing Clinical Trials on Taminadenant

  • Study on the Safety and Tolerability of Spartalizumab for Patients with Advanced Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Hungary Italy +2

Glossary

  • Advanced cancer: Cancer that has spread to other parts of the body and is typically difficult to cure or control with treatment.
  • Clinical benefit: A positive effect of a treatment on a patient's disease or condition, as determined by their doctor.
  • Investigational drug: A medication that is being tested in clinical trials but has not yet been approved by regulatory agencies for general use.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being given.
  • Rollover protocol: A study design that allows participants from previous trials to continue receiving treatment in a new study.
  • Adverse events (AEs): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Serious adverse events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, cause persistent disability, or have other significant medical consequences.
  • Dose interruption: A temporary stop in the administration of a medication during a clinical trial, usually due to side effects or safety concerns.
  • Dose reduction: Lowering the amount of medication given to a patient during a clinical trial, typically in response to side effects or safety concerns.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-spartalizumab-for-patients-with-advanced-cancer/