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TSN084 for Cancer
Study Summary
This trial is testing a new drug called TSN084 to see if it can help treat cancer. The study will assess how well the drug works and if it has any side effects.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I am currently being treated for a mental health disorder.I do not have an active syphilis or tuberculosis infection.I am not taking medication that strongly affects drug metabolism.I am not expected to receive other cancer treatments during the study, except for palliative radiotherapy.My organs are working well.I agree to use birth control during and for 6 months after the study.My side effects from previous cancer treatments have mostly gone away.I have active hepatitis B with a high viral load.I have other health conditions that are not under control.I have not had major surgery in the last 4 weeks.I have severe lung disease or a history of it.I have difficulty swallowing.I have a cancer that has spread, with at least one tumor that can be measured.I have a condition that could affect how my body handles medication.My brain cancer has been stable for 4 weeks after treatment and I don't need steroids.I am fully active or restricted in physically strenuous activity but can do light work.I have an active hepatitis C infection with high viral levels.
- Group 1: TSN084
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are participating in this research endeavor?
"Affirmative, information posted on clinicaltrials.gov demonstrates that this trial is currently recruiting participants. This medical research study was first made available to the public on February 18th 2022 and has since undergone an update as of April 22nd 2022. The project requires 74 people from a single location to partake in it."
Are there any vacant positions for study participants?
"According to the information shared on clinicaltrials.gov, this research initiative is still searching for participants; it was posted on February 18th 2022 and subsequently updated April 22nd of that same year."
What are the objectives of this clinical experiment?
"As reported by the clinical trial sponsor, Tyligand Bioscience (Shanghai) Limited, the primary outcome evaluated is Treatment-Emergent Adverse Events over a 28 day period. Additionally, this investigation will be assessing secondary outcomes such as Duration of Response measured according to RECIST v1.1 criteria; Maximum Plasma Concentration in order to analyse pharmacokinetic properties of TSN084; and Area Under Curve from time 0 until last measurable concentration for further evaluation of said medication's PK features."
Has the Federal Drug Administration sanctioned TSN084?
"Due to the preliminary nature of Phase 1 trials, our risk assessment determined that TSN084 receives a score of 1 for safety. This is based on limited data points in terms of efficacy and safety."
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