Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01723202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-17
First Post:
2012-10-22
Brief Title:
Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer
Sponsor:
Bhavana Konda
Organization:
Ohio State University Comprehensive Cancer Center
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCCNGSK20008 | OTHER | National Comprehensive Cancer Network NCCN | None |
| NCI-2012-01700 | REGISTRY | None | None |