Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-17
Brief Title:
Study of Targeted Therapy vs Chemotherapy in Patients With Thyroid Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment refractory and which expresses a BRAF V600E mutation Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene Trametinib is also an enzyme inhibitor It binds to and inhibits the activity of proteins called MEK 1 and 2 which play a key role in activating pathways that regulate cell growth This may inhibit the growth of tumor cells mediated by these pathways The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib This trial may help researchers decide which treatment option cabozantinib alone or dabrafenib in combination with trametinib is safer andor more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer
Detailed Description:
PRIMARY OBJECTIVE
I To compare progression-free survival PFS in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
SECONDARY OBJECTIVES
I To compare the objective response rate in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
II To compare the duration of response in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
III To compare the overall survival in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
IV To compare the PFS2 in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
V To compare the safetytolerability in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
QUALITY OF LIFE OBJECTIVE
I To assess patient tolerability of treatment using the Functional Assessment Cancer Therapy General FACT GP5 and general quality of life using the FACT-G7
OUTLINE Patients are randomized to 1 of 2 arms Patients may crossover to other treatment arm at the time of progression
ARM A Patients receive dabrafenib orally PO twice per day BID and trametinib PO once per day QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan blood sample collection and may undergo magnetic resonance imaging MRI throughout the study
ARM B Patients receive cabozantinib PO QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo CT scan blood sample collection and may undergo MRI throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months thereafter up to 5 years
I To compare progression-free survival PFS in patients with BRAF V600Em differentiated thyroid cancer who progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
SECONDARY OBJECTIVES
I To compare the objective response rate in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
II To compare the duration of response in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
III To compare the overall survival in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
IV To compare the PFS2 in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
V To compare the safetytolerability in patients with BRAF V600Em differentiated thyroid cancer that progressed on frontline multikinase inhibitor treated with dabrafenibtrametinib or cabozantinib
QUALITY OF LIFE OBJECTIVE
I To assess patient tolerability of treatment using the Functional Assessment Cancer Therapy General FACT GP5 and general quality of life using the FACT-G7
OUTLINE Patients are randomized to 1 of 2 arms Patients may crossover to other treatment arm at the time of progression
ARM A Patients receive dabrafenib orally PO twice per day BID and trametinib PO once per day QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan blood sample collection and may undergo magnetic resonance imaging MRI throughout the study
ARM B Patients receive cabozantinib PO QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo CT scan blood sample collection and may undergo MRI throughout the study
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months thereafter up to 5 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03023 | REGISTRY | None | None |
| EA3231 | OTHER | None | None |
| EA3231 | OTHER | None | None |
| U10CA180820 | NIH | None | None |