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Niraparib + Dostarlimab + Radiation for Rectal Cancer (TOPAZ Trial)

Phase 1 & 2
Recruiting
Led By Joseph M. Caster, M.D., Ph.D.
Research Sponsored by Joseph Caster, Ph.D., M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Resectable locally advanced rectal cancer (i.e., T3 to T4 or T1-T4 with N1-2 M0)
Age at least 18 years at the time of study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at surgery; up to 1 year post-treatment
Awards & highlights

TOPAZ Trial Summary

This trial is designed to find the best dose of niraparib to combine with dostarlimab and hypofractionated radiation for locally advanced rectal cancer, and to see what effect this has on the tumor and patient reported outcome measures.

Who is the study for?
Adults at least 18 years old with resectable locally advanced rectal cancer (T3 to T4 or N1-2 M0) who can consent, have an adequate performance status, and are recommended for preoperative radiation therapy. Participants must not donate blood during the study and agree to lifestyle considerations. Exclusions include certain blood count levels, liver function abnormalities, uncontrolled hypertension, recent major surgery or vaccines, other cancer treatments within specific timeframes, known hypersensitivities or severe reactions to similar drugs.Check my eligibility
What is being tested?
The trial is testing the highest dose of niraparib that's safe when given with dostarlimab and short course radiation in patients with rectal cancer. It aims to find out how this combination affects both tumor response and patient-reported outcomes.See study design
What are the potential side effects?
Potential side effects may include fatigue, nausea, low blood cell counts leading to increased infection risk or bleeding problems; heartburn; changes in liver function tests; allergic reactions; high blood pressure; and possibly others as it's a safety study.

TOPAZ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My rectal cancer is advanced but can be surgically removed.
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I am 18 years old or older.
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I am mostly active and can carry out daily activities.
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I am advised to undergo radiation therapy before surgery.

TOPAZ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at surgery; up to 1 year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at surgery; up to 1 year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of recommended phase 2 niraparib dose
Determination of the clinical complete response rate
Secondary outcome measures
Determination of the organ preservation rate
Determination of the pathologic complete response
Determine local recurrence free survival
+5 more

TOPAZ Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment3 Interventions
niraparib, 200 mg orally once daily for up to 12 weeks dostarlimab, 500 mg infused (IV) once every 3 weeks for up to 12 weeks radiation therapy, 5 Gray (Gy) per day for 5 consecutive days
Group II: Cohort 1 (starting)Experimental Treatment3 Interventions
niraparib, 100 mg orally once daily for up to 12 weeks dostarlimab, 500 mg infused (IV) once every 3 weeks for up to 12 weeks radiation therapy, 5 Gray (Gy) per day for 5 consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Dostarlimab
2020
Completed Phase 2
~1000

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,748 Previous Clinical Trials
8,067,474 Total Patients Enrolled
Joseph Caster, Ph.D., M.D.Lead Sponsor
Joseph M. Caster, M.D., Ph.D.Principal InvestigatorUniversity of Iowa

Media Library

Short course radiation Clinical Trial Eligibility Overview. Trial Name: NCT04926324 — Phase 1 & 2
Rectal Cancer Research Study Groups: Cohort 1 (starting), Cohort 2
Rectal Cancer Clinical Trial 2023: Short course radiation Highlights & Side Effects. Trial Name: NCT04926324 — Phase 1 & 2
Short course radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04926324 — Phase 1 & 2
Rectal Cancer Patient Testimony for trial: Trial Name: NCT04926324 — Phase 1 & 2

Frequently Asked Questions

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

Are volunteers still needed for this clinical trial?

"The information available on clinicaltrials.gov affirms that this trial is actively recruiting patients. The listing was first created on 7/7/2022 and has since been updated on 7/22/2022. At present, the study requires 38 participants at a single site."

Answered by AI

What is the general consensus in the medical community about Short course radiation?

"There are 112 ongoing studies related to Short course radiation, with 14 of them in Phase 3. Many research centres for this topic are based in Washington D.C., but there are 3147 locations conducting trials globally."

Answered by AI

What are researchers hoping to achieve with this clinical trial?

"The primary outcome of this study, according to GlaxoSmithKline, will be measured over a 21 week period starting from day one of treatment. This medical research is also investigating secondary outcomes like local recurrence free survival (defined as the time until disease progression or death), metastasis free survival (defined as the time until documented disease progression or death), and overall survival (the time from treatment day 1 until death)."

Answered by AI

How many study participants are being treated with the experimental therapy?

"Yes, that is accurate. The trial was posted on 7/7/2022 and was last updated almost two weeks ago on 7/22/2022. They are currently 38 patients needed from 1 site."

Answered by AI

When is it common to use radiation therapy for a short amount of time?

"While frequently used to treat primary peritoneal cancer, short course radiation can also be an effective treatment for advanced mismatch repair-deficient (dmmr) endometrial cancer, disease that has progressed during or following platinum-containing chemotherapy, and fallopian tubes cancer."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Holden Comprehensive Cancer Center at the University of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Wanted to try other options.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Holden Comprehensive Cancer Center at the University of Iowa: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call
~12 spots leftby Dec 2024