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3-[6-(1-Benzylpiperidin-4-Yl)-3-Oxo-1H-Isoindol-2-Yl]Piperidine-2,6-Dione

This article discusses the ongoing clinical trials investigating the use of DKY709, also known as 3-[6-(1-Benzylpiperidin-4-Yl)-3-Oxo-1H-Isoindol-2-Yl]Piperidine-2,6-Dione, in the treatment of advanced cancer. The drug is being studied as part of a rollover trial to assess its safety and tolerability, both as a single agent and in combination with other treatments. This research aims to provide continued access to potentially beneficial treatments for patients who have participated in previous Novartis-sponsored studies.

Table of Contents

Introduction to the Drug

The drug with the complex chemical name 3-[6-(1-BENZYLPIPERIDIN-4-YL)-3-OXO-1H-ISOINDOL-2-YL]PIPERIDINE-2,6-DIONE is an investigational medication being studied for the treatment of various types of advanced cancer. This drug is also known by its simpler names DKY709 or NVP-DKY709, which are easier to remember and pronounce.[1]

Medical Conditions Treated

The primary focus of this drug is on treating different types of advanced cancer. Advanced cancer refers to cancer that has spread from its original site to other parts of the body or has become resistant to standard treatments. This medication is being investigated as a potential option for patients who have already participated in previous studies involving a drug called spartalizumab, either alone or in combination with other treatments.[1]

Current Clinical Trial

A clinical trial is currently underway to further study this drug. The trial is described as an “open-label, multi-center rollover protocol”. Here’s what this means:

  • Open-label: Both the researchers and participants know which treatment is being given.
  • Multi-center: The study is conducted at multiple hospitals or research centers.
  • Rollover protocol: It allows patients who participated in previous studies to continue receiving the treatment if they are benefiting from it.

The main objectives of this trial are:

  1. To collect data on the safety and tolerability of the drug when used alone or in combination with other treatments.
  2. To provide continued access to the drug for patients who were previously enrolled in studies and are still benefiting from the treatment.[1]

Drug Administration

The medication comes in the form of a hard capsule and is taken orally (by mouth). The exact dosage and frequency of administration may vary depending on individual patient factors and will be determined by the healthcare provider overseeing the treatment.[1]

Eligibility for Treatment

To be eligible for this treatment, patients must meet certain criteria:

  • Currently enrolled in a pre-defined Novartis-sponsored study and receiving spartalizumab alone or with other treatments.
  • Experiencing clinical benefit from the treatment, as determined by their doctor.
  • Have shown compliance with the requirements of the previous study.
  • Willing and able to comply with scheduled visits and treatment plans.
  • Must not have been permanently discontinued from spartalizumab in the previous study for any reason other than enrollment in this new study.[1]

Safety and Monitoring

The primary focus of this study is to gather more information about the safety and tolerability of the drug. Researchers will be closely monitoring:

  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the treatment.
  • Serious adverse events (SAEs): AEs that result in hospitalization, disability, or are life-threatening.
  • The frequency of dose interruptions and reductions.
  • The duration of exposure to the drug.[1]

This ongoing monitoring helps ensure patient safety and provides valuable information about how well the drug is tolerated over extended periods.

Aspect Details
Drug Name DKY709 (Spartalizumab)
Chemical Name 3-[6-(1-Benzylpiperidin-4-Yl)-3-Oxo-1H-Isoindol-2-Yl]Piperidine-2,6-Dione
Study Type Open-label, multi-center rollover protocol
Target Condition Different types of advanced cancer
Primary Objective Collect safety and tolerability data
Secondary Objective Provide continued access to study treatment
Administration Oral use (hard capsules)
Primary Endpoint Frequency and nature of adverse events, dose interruptions, and dose reductions
Secondary Endpoint Number of subjects receiving treatment and duration of exposure
Eligibility Currently enrolled in a Novartis-sponsored study, receiving clinical benefit, and demonstrating compliance

FAQ

  • What is DKY709? DKY709 is an investigational drug with the chemical name 3-[6-(1-Benzylpiperidin-4-Yl)-3-Oxo-1H-Isoindol-2-Yl]Piperidine-2,6-Dione. It is being studied for the treatment of various types of advanced cancer.
  • What is the main objective of the clinical trial involving DKY709? The main objective of the trial is to collect safety and tolerability data for DKY709 (also known as spartalizumab) when used alone or in combination with other study treatments in patients with advanced cancer.
  • Who is eligible to participate in this clinical trial? Eligible participants are those who are currently enrolled in a pre-defined Novartis-sponsored study, receiving DKY709 (spartalizumab) alone or in combination with other treatments, and are deriving clinical benefit from the treatment as determined by their doctor.
  • How is the drug administered in the trial? DKY709 is administered orally in the form of hard capsules. The exact dosage and treatment duration may vary based on individual patient needs and responses.
  • What are the primary endpoints of the study? The primary endpoints of the study are the frequency and nature of adverse events (AEs) and serious adverse events (SAEs), as well as the number of patients requiring dose interruptions or reductions during treatment with DKY709.

Ongoing Clinical Trials on 3-[6-(1-Benzylpiperidin-4-Yl)-3-Oxo-1H-Isoindol-2-Yl]Piperidine-2,6-Dione

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

    Not recruiting

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

Glossary

  • Spartalizumab: Another name for the investigational drug DKY709, which is being studied for the treatment of advanced cancer.
  • Rollover study: A type of clinical trial that allows patients who have participated in a previous study to continue receiving the investigational treatment if they are benefiting from it.
  • Advanced cancer: Cancer that has spread from its original site to other parts of the body or has progressed despite treatment.
  • 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 or significant disability, or lead to birth defects.
  • Dose interruption: Temporarily stopping the administration of a drug during treatment, usually due to side effects or other medical reasons.
  • Dose reduction: Decreasing the amount of medication given to a patient, typically in response to side effects or other concerns.
  • Single agent: The use of one drug alone in treatment, without combining it with other medications.
  • Combination therapy: The use of two or more drugs or treatments together to achieve better results in treating a condition.
  • Investigational treatment: A drug or therapy that is still being studied and has not yet been approved for general use by regulatory authorities.

References

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