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Cytidine Deaminase Inhibitor

Decitabine + Cedazuridine for Solid Tumors

Phase 1
Waitlist Available
Led By Nilofer Azad, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition
Ability to swallow oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced solid tumors who've tried at least two treatments without success or declined other beneficial therapies. They must be in good physical condition (ECOG <1), able to swallow pills, and have measurable tumor growth. People can't join if they have recent ulcers, bowel blockages, chemotherapy or radiotherapy within the last 3 weeks, are on other experimental drugs, or have active hepatitis B/C or symptomatic ascites.Check my eligibility
What is being tested?
The study tests different doses of Cedazuridine combined with Decitabine in patients with solid tumors to find the best dose that modifies DNA methylation without causing too much toxicity. At least six people will be tested per dose level up to a total of thirty participants.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea and vomiting due to Decitabine and Cedazuridine's impact on the digestive system; fatigue; blood count changes leading to anemia or infection risk; liver function changes; and mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had at least 2 treatments for my advanced cancer and there are no other options or I refuse them.
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I can swallow pills.
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My cancer is advanced, cannot be surgically removed, and has spread.
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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) as determined by number of participants with of dose limiting toxicities (DLT)
Safety and tolerability of combination cedazuridine with decitabine as assessed by number of participants who experience adverse events
Secondary outcome measures
Objective response rate (ORR) in solid tumor patients who are treated with ASTX727
Pharmacokinetics of ASTX727 in solid tumor patients as measured by maximum concentration (Cmax)
Pharmacokinetics of ASTX727 in solid tumor patients as measured by time to maximum concentration (Tmax)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Decitabine and CedazuridineExperimental Treatment2 Interventions
Treatment will be administered on an outpatient basis. Cycle length is 28 days. The dose of cedazuridine is fixed at 100mg and the dose and duration of decitabine will vary depending on when a patient enters the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Cedazuridine
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,882 Total Patients Enrolled
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,936 Total Patients Enrolled
Nilofer Azad, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
10 Previous Clinical Trials
248 Total Patients Enrolled

Media Library

Cedazuridine (Cytidine Deaminase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03875287 — Phase 1
Solid Tumors Research Study Groups: Decitabine and Cedazuridine
Solid Tumors Clinical Trial 2023: Cedazuridine Highlights & Side Effects. Trial Name: NCT03875287 — Phase 1
Cedazuridine (Cytidine Deaminase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03875287 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~5 spots leftby Mar 2025