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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

NCT04940052 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-05-22

Study results available
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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.

Conditions

  • Differentiated Thyroid Cancer (DTC)

Interventions

DRUG

Dabrafenib

Dabrafenib 150 mg capsule administered orally twice a day (BID)

DRUG

Trametinib

Trametinib 2 mg tablet administered once a day (QD)

DRUG

Trametinib Placebo

matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD)

DRUG

Dabrafenib placebo

matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2025-01-22
Completion
2027-05-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • India
  • Malaysia
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04940052 on ClinicalTrials.gov