In short
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.
At a glance
- 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
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.
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.
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:
- To collect data on the safety and tolerability of the drug when used alone or in combination with other treatments.
- To provide continued access to the drug for patients who were previously enrolled in studies and are still benefiting from the treatment.
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.
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.
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.
This ongoing monitoring helps ensure patient safety and provides valuable information about how well the drug is tolerated over extended periods.