Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02296112
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2014-11-17
Brief Title:
Trametinib in Treating Patients With Advanced Melanoma With BRAF Non-V600 Mutations
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
A Phase II Open-Label Two-Arm Study of the MEK Inhibitor Trametinib to Investigate the Safety and Anti-Cancer Activity in Subjects With Melanoma With BRAF Non-V600 Mutations
Status:
COMPLETED
Status Verified Date:
2021-05
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 II trial studies trametinib in treating patients with melanoma with v-Raf murine sarcoma viral oncogene homolog B BRAF non-V600 mutations that has spread to other places in the body Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the clinical efficacy of trametinib in advanced BRAF nonV600mutation MUT melanoma high activity group
SECONDARY OBJECTIVES
I To characterize the safety of trametinib II To evaluate the progression-free survival PFS and overall survival OS of trametinib in advanced BRAF nonV600MUT melanoma
TERTIARY OBJECTIVES
I To determine the clinical efficacy of trametinib in advanced BRAF nonV600MUT melanoma low activityunknown group
II Identify mechanisms of resistance to trametinib in this patient population
OUTLINE
Patients receive trametinib orally PO once daily QD on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 28 days
I To determine the clinical efficacy of trametinib in advanced BRAF nonV600mutation MUT melanoma high activity group
SECONDARY OBJECTIVES
I To characterize the safety of trametinib II To evaluate the progression-free survival PFS and overall survival OS of trametinib in advanced BRAF nonV600MUT melanoma
TERTIARY OBJECTIVES
I To determine the clinical efficacy of trametinib in advanced BRAF nonV600MUT melanoma low activityunknown group
II Identify mechanisms of resistance to trametinib in this patient population
OUTLINE
Patients receive trametinib orally PO once daily QD on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| P30CA068485 | NIH | Vanderbilt-Ingram Cancer Center | httpsreporternihgovquickSearchP30CA068485 |
| NCI-2014-02185 | REGISTRY | None | None |
| MEL1457 | None | None | None |
| GSK1120212 | None | None | None |
| VICC MEL 1457 | OTHER | None | None |