Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 11:08 PM
Study NCT ID:
NCT02749903
Status:
UNKNOWN
Last Update Posted:
2021-10-26
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study will test any good and bad effects of the study drug called enzalutamide. Enzalutamide could shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by at least 30% compared to its present size, in at least 1 out of 5 patients. Enzalutamide is not FDA approved to treat salivary gland cancer, but it has already been FDA-approved to treat other cancers.
Detailed Description:
This single arm Phase II trial will assess the best overall response associated with enzalutamide in patients with AR-positive salivary cancers. Given that this will be one of the first prospective studies ever conducted for AR-positive salivary cancers, and there are currently no standard therapies known to be effective for this disease, the investigators will adopt a best overall response (BOR) of 5% as the null hypothesis and BOR of 20 % as the alternative hypothesis. In addition to response, this study will also evaluate the progression-free survival (PFS), overall survival (OS), adverse events, and will also try to identify molecular predictors of response by examining genomic and transcriptional elements of androgen receptor biology.
The primary and secondary objectives of the study:
Primary objective
To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers
Secondary objectives
1. To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
2. To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
3. To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer
Patients are followed up to 3 years after study enrollment.
The primary and secondary objectives of the study:
Primary objective
To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers
Secondary objectives
1. To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
2. To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
3. To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer
Patients are followed up to 3 years after study enrollment.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-01706 | REGISTRY | NCI Clinical Trial Reporting Program | View |