Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01723202
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2012-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer
Sponsor:
Bhavana Konda
Organization:
Study Overview
Official Title:
A Randomized Phase 2 Study of Single Agent Dabrafenib (BRAFi) vs. Combination Regimen Dabrafenib (BRAFi) and Trametinib (MEKi) in Patients With BRAF Mutated Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial studies how well dabrafenib works with or without trametinib in treating patients with recurrent thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether dabrafenib is more effective when given with or without trametinib in treating thyroid cancer
Detailed Description:
PRIMARY OBJECTIVES:
I. To screen two different regimens (GSK2118436 \[BRAFi\] \[dabrafenib\] as a single agent versus the combination regimen of GSK2118436 \[BRAFi\] and GSK1120212 \[MEKi\] \[trametinib\]) and identify which regimen is more promising for subsequent testing in a phase III trial in radioiodine refractory BRAF-mutated differentiated thyroid cancer (DTC) patients.
SECONDARY OBJECTIVES:
I. To understand duration of objective response, progression-free survival and overall survival for each treatment group.
II. To assess tolerability and adverse events of GSK2118436 (BRAFi) as a single agent and the tolerability and adverse events of GSK2118436 (BRAFi) and GSK1120212 (MEKi) in combination, in patients with DTC.
III. To evaluate impact of experimental drugs on serum tumor marker thyroglobulin and its correlation with overall response rate.
IV. To understand pharmacokinetic, pharmacogenetics and pharmacodynamics of experimental drugs using serial tumor biopsies, tumor blocks and peripheral blood.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28. Patients with disease progression may cross-over to arm II.
ARM II: Patients receive dabrafenib PO BID and trametinib PO once daily (QD) on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
I. To screen two different regimens (GSK2118436 \[BRAFi\] \[dabrafenib\] as a single agent versus the combination regimen of GSK2118436 \[BRAFi\] and GSK1120212 \[MEKi\] \[trametinib\]) and identify which regimen is more promising for subsequent testing in a phase III trial in radioiodine refractory BRAF-mutated differentiated thyroid cancer (DTC) patients.
SECONDARY OBJECTIVES:
I. To understand duration of objective response, progression-free survival and overall survival for each treatment group.
II. To assess tolerability and adverse events of GSK2118436 (BRAFi) as a single agent and the tolerability and adverse events of GSK2118436 (BRAFi) and GSK1120212 (MEKi) in combination, in patients with DTC.
III. To evaluate impact of experimental drugs on serum tumor marker thyroglobulin and its correlation with overall response rate.
IV. To understand pharmacokinetic, pharmacogenetics and pharmacodynamics of experimental drugs using serial tumor biopsies, tumor blocks and peripheral blood.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive dabrafenib orally (PO) twice daily (BID) on days 1-28. Patients with disease progression may cross-over to arm II.
ARM II: Patients receive dabrafenib PO BID and trametinib PO once daily (QD) on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: