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NCT04940052 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
A Phase 3 study of Differentiated Thyroid Cancer (DTC), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT04940052: Active Phase 3 study of Differentiated Thyroid Cancer (DTC), sponsored by Novartis Pharmaceuticals.
NCT04940052 is a Phase 3 study of Differentiated Thyroid Cancer (DTC) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04940052, a Phase 3 study of Differentiated Thyroid Cancer (DTC), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.
Primary Outcome
Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 Ja
Conditions Studied
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
- DRUG Trametinib Placebo
- DRUG Dabrafenib placebo
Study Locations (20)
Jiangsu
- Novartis Investigative Site - Nanjing
- Novartis Investigative Site - Nanjing
- Novartis Investigative Site - Xuzhou
Other
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Beijing
Illinois
- Northwestern University Med School - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Buenos Aires
- Novartis Investigative Site - CABA
Rio de Janeiro
- Novartis Investigative Site - Rio de Janiero
Santa Catarina
- Novartis Investigative Site - Blumenau
São Paulo
- Novartis Investigative Site - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2027-06-04 |
| Phase | Phase 3 |
What the registry record for NCT04940052 still lists
NCT04940052 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Differentiated Thyroid Cancer (DTC) appearing as the primary indexed condition, and to 4 interventions - of which Trametinib is the first listed.
NCT04940052 names 20 study sites across 17 states, led by Jiangsu, Other, Illinois.
Frequently Asked Questions
What is clinical trial NCT04940052 about?
NCT04940052 is a clinical study titled "Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer". The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and...
What is the current status of trial NCT04940052?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2021-11-15. Estimated completion is 2027-06-04.
What conditions does trial NCT04940052 study?
This clinical trial studies the following conditions: Differentiated Thyroid Cancer (DTC).
What interventions are being tested in trial NCT04940052?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG), Trametinib Placebo (DRUG), Dabrafenib placebo (DRUG).
Who is sponsoring clinical trial NCT04940052?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04940052 being conducted?
This trial has 20 study locations across Illinois, Massachusetts, Buenos Aires, Rio de Janeiro, Santa Catarina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04940052's enrollment target sits among peer trials
153 1511th of 2000 higher than 488 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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