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Tolinapant + Radiation for Head and Neck Cancer

Q: Are new participants still being accepted for this research?

<p>Indeed, this clinical trial is currently seeking participants. The initial posting date was February 17th 2022 and the most recent update to the listing occurred on that same day.</p>

Q: How many participants are contributing data to this clinical trial?

<p>Indeed, based on the data published on clinicaltrials.gov, this research project is actively looking for participants and was first posted in February 17th 2022 with no subsequent changes recorded since then. The trial requires 10 people to join at one medical site.</p>

Phase < 1

Recruiting

Led By Nicole C Schmitt, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of HNSCC, previously untreated and locally advanced, for whom definitive or adjuvant radiation is planned but cisplatin chemotherapy is contraindicated

ECOG performance status ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety and side effects of combining tolinapant with radiation therapy to treat head and neck cancer in patients who haven't received treatment before, can't receive cisplatin, and have cancer that's spread to nearby tissue or lymph nodes.

Who is the study for?

Adults with previously untreated, locally advanced head and neck cancer who cannot receive cisplatin. They must be in good physical condition (ECOG ≤1), have acceptable organ function, no severe hearing loss or neuropathy, and not be pregnant or breastfeeding. Participants need to use effective contraception and cannot have a history of significant mental illness or substance abuse.Check my eligibility

What is being tested?

The trial is testing the combination of a new drug called Tolinapant with radiation therapy against head and neck cancers that can't be treated with cisplatin. The goal is to see if this combo is safe and more effective at killing cancer cells than standard treatments.See study design

What are the potential side effects?

Potential side effects include typical reactions from radiation like skin irritation, fatigue, dry mouth/throat issues, as well as possible effects from Tolinapant such as nausea, vomiting, diarrhea, blood count changes which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a confirmed diagnosis of head and neck cancer that hasn't been treated yet, and I can't receive cisplatin with my radiation.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Feasibility of Tolinapant + Radiation (number of patients able to complete treatment)

Safety of Tolinapant + Radiation (number of patients with adverse events per CTCAE v5.0)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tolinapant, radiation therapy)Experimental Treatment2 Interventions

Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,638 Previous Clinical Trials

2,560,522 Total Patients Enrolled

Astex Pharmaceuticals, Inc.Industry Sponsor

95 Previous Clinical Trials

7,951 Total Patients Enrolled

Nicole C Schmitt, MDPrincipal InvestigatorEmory University

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05245682 — Phase < 1

Head and Neck Cancers Research Study Groups: Treatment (tolinapant, radiation therapy)

Head and Neck Cancers Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT05245682 — Phase < 1

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245682 — Phase < 1

Frequently Asked Questions

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

Are new participants still being accepted for this research?

"Indeed, this clinical trial is currently seeking participants. The initial posting date was February 17th 2022 and the most recent update to the listing occurred on that same day."

Answered by AI

How many participants are contributing data to this clinical trial?

"Indeed, based on the data published on clinicaltrials.gov, this research project is actively looking for participants and was first posted in February 17th 2022 with no subsequent changes recorded since then. The trial requires 10 people to join at one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

Nicole Schmitt 2022. "Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05245682.