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RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) for Mouth Sore (KEVLARx Trial)

Phase 2

Recruiting

Research Sponsored by EpicentRx, 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 estimated up to 18 months

Awards & highlights

KEVLARx Trial Summary

This trial aims to see if adding RRx-001 to the standard treatment of cisplatin and radiation therapy can help reduce severe oral mucositis in patients with head and neck cancers. Patients will

Who is the study for?

This trial is for adults with squamous cell carcinoma of the oral cavity or oropharynx, who can undergo standard radiation and cisplatin chemotherapy. They must have an ECOG performance status ≤ 2, acceptable organ function tests, documented HPV status if applicable, and agree to use contraception. Prior surgery patients are eligible if recovered.Check my eligibility

What is being tested?

The study is testing whether RRx-001 reduces severe mouth sores when added to standard chemotherapy (cisplatin) and radiation therapy in head and neck cancer patients. Everyone gets the usual treatment; some will also get RRx-001 while others receive a placebo before starting treatment.See study design

What are the potential side effects?

Possible side effects include those from standard chemo like nausea, kidney issues, hearing changes, blood count drops leading to increased infection risk; radiation may cause skin problems at treated sites. Specific side effects of RRx-001 are not detailed but could be similar.

KEVLARx Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated up to 18 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

Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)

Secondary outcome measures

Cumulative radiation dose to onset of SOM

Duration of Severe Oral Mucositis (SOM) through 60 Gy

Duration of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)

+5 more

KEVLARx Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)Experimental Treatment3 Interventions

Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period

Group II: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)Experimental Treatment3 Interventions

Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period.

Group III: Placebo Pre-Treatment + Chemoradiation Therapy (CRT)Placebo Group2 Interventions

No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity Modulated Radiation Therapy (IMRT)

2010

Completed Phase 1

~60

RRx-001

2015

Completed Phase 2

~290

Do I qualify?Apply below to find out

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Who is running the clinical trial?

EpicentRx, Inc.Lead Sponsor

15 Previous Clinical Trials

838 Total Patients Enrolled

Meaghan StirnStudy DirectorEpicentRx, Inc.

Frequently Asked Questions

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

What is the main objective of this clinical trial?

"The primary objective of this study, assessed over an anticipated period of up to 18 months, is to examine the occurrence of Severe Oral Mucositis during a radiation treatment plan delivering 60 Gy. Secondary endpoints encompass the Duration of Severe Oral Mucositis (SOM) under Intensity-modulated radiation therapy (IMRT), represented as DoSOM. The principal analysis involves evaluating the Probability of Being in Response (PBIR), a straightforward measure derived from understanding that response duration can be quantified by assessing the area under the curve defined by exposure duration on one axis and response probability on another. Furthermore, comparing the"

Answered by AI

Is the enrollment for participants currently open in this clinical trial?

"As per information available on clinicaltrials.gov, this particular study is no longer accepting new participants. Originally listed on April 2nd, 2024, and most recently updated on March 25th, 2024. Despite the closure of this trial to enrollment, there are currently 72 other active studies seeking eligible candidates."

Answered by AI

Has the combination of pre-treatment with 8mg RRx-001 followed by chemoradiation therapy (CRT) received approval from the Food and Drug Administration (FDA)?

"With a score of 2, the safety evaluation for RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT) is based on Phase 2 trial data. This indicates some evidence supporting its safety profile but lacks efficacy data at this stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

2024. "RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05966194.