← Back to Search

Tyrosine Kinase Inhibitor

Pralsetinib for Medullary Thyroid Cancer (AcceleRET-MTC Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 years
Awards & highlights

AcceleRET-MTC Trial Summary

This trial will compare the effectiveness of a new drug, pralsetinib, to the standard of care (SOC) treatment for people with a specific type of thyroid cancer. Participants will be randomly assigned to either the new drug or the SOC treatment. If their disease progresses while taking the SOC treatment, they will be offered the new drug.

Who is the study for?
This trial is for adults and adolescents with advanced or metastatic Medullary Thyroid Cancer (MTC) that has a specific mutation (RET). They should not have had previous MultiKinase Inhibitor therapy, be able to take oral meds, and agree to use contraception. Excluded are those with recent major surgery, active infections, certain medical conditions, prior malignancies within 2 years, known drug hypersensitivity, or who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study compares the effectiveness of Pralsetinib against standard treatments Cabozantinib or Vandetanib in treating RET-mutated MTC. Participants will randomly receive either Pralsetinib or the investigator's choice of standard care drugs. If disease worsens on standard care, patients may switch to Pralsetinib.See study design
What are the potential side effects?
Pralsetinib and the other drugs can cause side effects like high blood pressure, fatigue, mouth sores, hand-foot syndrome (redness/pain/swelling in hands/feet), diarrhea and constipation. Serious but less common side effects include liver problems and bleeding.

AcceleRET-MTC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 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
Progression-Free Survival (PFS)
Secondary outcome measures
Acceptability and Palatability of Pralsetinib Capsules
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
+7 more

AcceleRET-MTC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (Pralsetinib)Experimental Treatment1 Intervention
Participants will receive pralsetinib at a dose of 400 milligrams (mg) orally once daily (PO QD) in 28-day cycles.
Group II: Arm B (SOC: Cabozantinib/Vandetanib)Active Control2 Interventions
Adult participants will receive investigator's choice of SOC MKI therapy with either 140 mg cabozantinib PO QD or 300 mg vandetanib PO QD in 28-day cycles. Adolescents participants (≥ 12 and < 18 years of age) will receive vandetanib, PO QD or every other day, in 28-day cycles depending on the body surface area (BSA), at a dose determined according to the dosing nomogram available in the E.U. Vandetanib SmPC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pralsetinib
2021
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,422 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,522 Total Patients Enrolled

Media Library

Pralsetinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04760288 — Phase 3
Medullary Thyroid Cancer Research Study Groups: Arm B (SOC: Cabozantinib/Vandetanib), Arm A (Pralsetinib)
Medullary Thyroid Cancer Clinical Trial 2023: Pralsetinib Highlights & Side Effects. Trial Name: NCT04760288 — Phase 3
Pralsetinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04760288 — Phase 3

Frequently Asked Questions

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

Are there any other similar drugs to Pralsetinib that have been studied?

"As of now, there are 133 clinical trials for Pralsetinib with 20 in Phase 3. The majority of these Pralsetinib trials are situated in Cordoba and Calabria, but there are 8199 total locations running these clinical trials."

Answered by AI

Does this research stand alone or has a similar study been done before?

"Pralsetinib has been under medical research for over a decade, with the first study sponsored by Genzyme in 2006. 437 people were a part of the initial study which led to the drug's approval for Phase 3 trials. There are currently 133 live trials involving Pralsetinib in 54 countries and 1425 cities."

Answered by AI

Has Pralsetinib undergone FDA approval procedures?

"Although this is a Phase 3 trial, meaning that there is some evidence to support its efficacy, there is also data from multiple rounds of testing that suggest that Pralsetinib is safe. For this reason, our team has given it a score of 3."

Answered by AI

For what purpose is Pralsetinib being taken by the majority of patients?

"Pralsetinib is used to treat various types of cancer, including those in the adrenal medulla, high risk patients, and medullary carcinoma of thyroid."

Answered by AI

How many men and women are taking part in this research project?

"Unfortunately, this particular clinical trial is not presently admitting any more patients. The trial was originally posted on 6/30/2023 and was last edited on 10/21/2022. However, if you are exploring other studies, there are currently 304 clinical trials actively admitting participants with thyroid diseases and 133 trials for Pralsetinib actively enrolling participants."

Answered by AI

Where can patients go to participate in this clinical trial?

"There are 10 sites currently recruiting patients for this study, 5 of which are in Canada. These include McGill University Health Center; Glen-Cedars Cancer Centre, Oncology Pharmacy in Montreal, The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente in Torrance, and Cross Cancer Institute; Clinical Trials in Edmonton."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).
2023. "A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04760288.
~0 spots leftby Oct 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top