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

Conditions

• Differentiated Thyroid Cancer (DTC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib — DRUG
  Dabrafenib 150 mg capsule administered orally twice a day (BID)
• Trametinib — DRUG
  Trametinib 2 mg tablet administered once a day (QD)
• Trametinib Placebo — DRUG
  matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD)
• Dabrafenib placebo — DRUG
  matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID)

Study Details

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.

Key Dates

Start date

Nov 15, 2021

Status verified

Jun 2026

Primary completion

Jan 22, 2025

Completion

May 17, 2027

Study Design

Enrollment

153 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Dabrafenib plus Trametinib
  Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor.
• Placebo Comparator: Dabrafenib Placebo plus Trametinib Placebo
  Eligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years ]

Locations (2)

Find similar trials in Chicago, IL

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