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Kinase Inhibitor

Dabrafenib + Trametinib for Thyroid Cancer

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female >= 18 years of age at the time of informed consent
BRAFV600E mutation positive tumor sample as per Novartis designated central laboratory result
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, week 4, week 8, week 12, week 20 and every 12 weeks after week 20, up to approximately 2 years
Awards & highlights

Study Summary

This trial is testing whether the combination of dabrafenib and trametinib is more effective than placebo for treating patients with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid carcinoma who are refractory to radioactive iodine and have progressed following prior VEGFR targeted therapy.

Who is the study for?
Adults over 18 with advanced thyroid cancer that's not responding to radioactive iodine and has a specific mutation (BRAFV600E) can join. They must have tried at least one but no more than two prior therapies targeting VEGFR, be in decent physical condition, and have at least one tumor that can be measured. People who've had certain other cancers or treatments recently, or those with eye disease risks, cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining Dabrafenib and Trametinib against placebos in patients whose thyroid cancer has worsened despite previous treatment. Participants will be randomly assigned to either the drug combo or placebo group in a 2:1 ratio based on their past treatments.See study design
What are the potential side effects?
Potential side effects from Dabrafenib and Trametinib may include fever, fatigue, skin rash, headache, joint pain, nausea, vomiting; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My tumor has the BRAFV600E mutation.
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My thyroid cancer does not respond to radioactive iodine treatment.
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My thyroid cancer has spread and was confirmed by lab tests.
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I need assistance with daily activities due to my health condition.
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My condition worsened after 1 or 2 treatments targeting VEGFR.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, week 4, week 8, week 12, week 20 and every 12 weeks after week 20, up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, week 4, week 8, week 12, week 20 and every 12 weeks after week 20, up to approximately 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
Progression Free Survival
Secondary outcome measures
Duration of response
Number of participants with trametinib associated serous retinopathy ocular events
Overall Response Rate
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dabrafenib plus trametinibExperimental Treatment2 Interventions
Participants will be treated with dabrafenib twice daily and trametinib once daily
Group II: Placebo dabrafenib plus placebo trametinibPlacebo Group2 Interventions
Participants will receive placebo dabrafenib twice daily and placebo trametinib once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,200 Total Patients Enrolled

Media Library

Dabrafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04940052 — Phase 3
Thyroid Cancer Research Study Groups: Placebo dabrafenib plus placebo trametinib, Dabrafenib plus trametinib
Thyroid Cancer Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT04940052 — Phase 3
Dabrafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04940052 — 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 unfilled positions in this clinical trial for testing new treatments?

"That is correct. The clinical trial, which was posted on November 15th 2021, is currently looking for participants. The trial is admitting 150 patients at 4 locations."

Answered by AI

What is the Dabrafenib research landscape?

"Dabrafenib was first trialled in 2012 by the University of Chicago Medical Center. To date, there have been 86 completed studies with dabrafenib. Right now, there are 99 clinical trials underway, with a large portion of these taking place in London, Alberta."

Answered by AI

Does Dabrafenib have any potentially life-threatening side effects?

"Dabrafenib is in Phase 3 of clinical trials, which means that while there is data supporting its efficacy, there is also multiple rounds of data supporting its safety. Our team at Power estimates the safety of Dabrafenib to be a 3 on a scale from 1 to 3."

Answered by AI

How many test subjects are being treated with this new medication?

"Yes, as of 10/24/2022, this clinical trial is still looking for 150 patients from 4 different sites. The trial was first posted on 11/15/2021."

Answered by AI

Does this study have a lot of participating locations within the state?

"There are 4 clinical sites running this trial presently. They are based in London, Edmonton, Calgary and 4 other locations. If you want to enroll, try and pick the location nearest you to cut down on travel."

Answered by AI

Who else is applying?

What state do they live in?
Alberta
How old are they?
18 - 65
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer
2021. "Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04940052.
All > Thyroid Cancer > Thyroid
~14 spots leftby Jul 2024
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