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Decitabine + Cedazuridine for Solid Tumors
Study Summary
This trial is testing a new cancer treatment combining cedazuridine with decitabine. Up to 30 patients will be enrolled to see if it is effective and has minimal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 can swallow pills.My cancer is advanced, cannot be surgically removed, and has spread.I am fully active and can carry on all my pre-disease activities without restriction.I've had at least 2 treatments for my advanced cancer and there are no other options or I refuse them.I have an active hepatitis B or C infection.I have had fluid build-up in my abdomen causing discomfort in the last 4 weeks.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I have an active or untreated stomach or upper small intestine ulcer.I have had a blockage in my bowel causing symptoms in the last 3 months.
- Group 1: Decitabine and Cedazuridine
- 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
What number of individuals have enrolled in the experiment thus far?
"Affirmative. According to the data provided on clinicaltrials.gov, this medical trial initiated recruitment on April 17th 2019 and was last updated in October 31st 2022. Currently it is enrolling 30 participants between two sites."
Can you enumerate any prior experiments that utilized Decitabine?
"Currently, there are 16 Phase 3 Decitabine clinical trials with 104 active studies. Philadelphia, Pennsylvania is the main hub for these investigations; however 1491 other locations around the world have begun trialling this medication as well."
Who is the ideal candidate for this research endeavor?
"The requirements for enrolment in this clinical trial are having cancer and being aged between 18-100 years old. As of now, 30 individuals can participate."
Is there an opportunity to join this research currently available?
"As per the details available on clinicaltrials.gov, this medical experiment is actively recruiting patients; it was first uploaded on April 17th 2019 and modified lastly on October 31st 2022."
Are those younger than 35 years of age admissible to this trial?
"The eligibility requirements for this trial specify that potential participants must be aged 18 or above and not exceed 100 years old."
What is the main purpose of this clinical experimentation?
"This medical investigation, lasting approximately two years, will assess the safety and tolerability of cedazuridine in combination with decitabine by tracking adverse events. Secondary objectives include analysing pharmacokinetics through measurements such as time to reach maximum concentration (Tmax), total exposure over a given period, and maximum concentration (Cmax) of ASTX727 present in blood samples."
What conditions can Decitabine be administered to alleviate?
"Decitabine is extensively used to treat intermediate-2 risk category of IPSS, as well as higher risk categories, refractory anemias and anaemia."
Has Decitabine been greenlit by the FDA?
"While prior clinical data is minimal, the perceived safety of Decitabine has been rated a 1. This assessment was based on it being in Phase 1 trials and lacking substantial evidence regarding efficacy."
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