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Radiosensitizer

Ropidoxuridine 960 mg for Glioblastoma

Phase 2

Waitlist Available

Research Sponsored by Shuttle Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months.

Awards & highlights

Study Summary

"This trial is testing a drug called ropidoxuridine to see if it can make radiation therapy more effective in patients with a specific type of brain cancer. The study will look at how safe and

Who is the study for?

This trial is for adults with a new diagnosis of IDH-wildtype glioblastoma, which is an aggressive brain cancer, and their tumors must have an unmethylated MGMT promoter. Participants should be ready to undergo standard radiotherapy.Check my eligibility

What is being tested?

The study tests ropidoxuridine's effectiveness in making tumor cells more sensitive to radiation therapy. It's a phase 2 trial where patients receive either the usual treatment or the same plus oral ropidoxuridine.See study design

What are the potential side effects?

Ropidoxuridine may increase sensitivity to radiation, potentially leading to enhanced side effects from radiotherapy such as fatigue, skin irritation at the treatment site, headaches, nausea, and hair loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.

Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.

Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.

+4 more

Secondary outcome measures

Best Overall Response

Disease Control Rate

Duration of Response

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Ropidoxuridine 960 mgExperimental Treatment1 Intervention

Ropidoxuridine is administered orally at 960 mg, 5 days a week for a total of 7 weeks, starting 1 week before the initiation of radiotherapy.

Group II: Ropidoxuridine 1200 mgExperimental Treatment1 Intervention

Ropidoxuridine is administered orally at 1200 mg, 5 days a week for a total of 7 weeks, starting 1 week before the initiation of radiotherapy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Shuttle Pharmaceuticals, Inc.Lead Sponsor

Frequently Asked Questions

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

At how many different sites is this clinical trial currently accessible?

"Enrollment for this clinical trial is ongoing at various prestigious medical centers such as Sylvester Comprehensive Cancer Center in Miami, John Theurer Cancer Center at the Hackensack University Medical Center in Hackensack, and Memorial Sloan Kettering Cancer Center in New york. Additionally, recruitment efforts are also underway at 6 other locations."

Answered by AI

What are the potential risks associated with administering Ropidoxuridine at a dosage of 960 mg to patients?

"The safety of Ropidoxuridine 960 mg is appraised at a level of 2 by our team at Power due to its Phase 2 trial status, indicating some existing safety data but lacking efficacy support."

Answered by AI

Are individuals currently being enrolled in this ongoing medical study?

"As per the details on clinicaltrials.gov, recruitment for this particular trial is not ongoing. The initial posting of this research endeavor was recorded on June 1st, 2024, with the most recent update noted on April 5th, 2024. While enrollment is paused for this study, it's important to note that there are currently 464 alternative trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter

2024. "Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06359379.

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