Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162377
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-11-30
Brief Title:
Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma MINK A Window of Opportunity Pilot Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma MINK A Window of Opportunity Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To learn if OCSCC patients can be safely given methylnaltrexone for 2 weeks before surgery
Detailed Description:
21 Primary Objectives
The primary objective of this study is to evaluate the feasibility of treating OCSCC participants with methylnaltrexone We define success as when a participants can receive assigned medication for two weeks preoperatively without interruption due to AEs NCI CTCAE v403 By the end of the trial feasibility is claimed if 90 or above the participants can successfully receive assigned medication
22 Secondary Objectives
The secondary objectives are to evaluate the endpoints include tolerability efficacy and tumor biological response of methylnaltrexone in surgical candidates for OCSCC
23 Exploratory Objectives
The exploratory objectives are to perform tumor RNASeq profiling and assess blood and tumor immunological landscape and to correlate efficacy endpoints with tumor biomarkers
The primary objective of this study is to evaluate the feasibility of treating OCSCC participants with methylnaltrexone We define success as when a participants can receive assigned medication for two weeks preoperatively without interruption due to AEs NCI CTCAE v403 By the end of the trial feasibility is claimed if 90 or above the participants can successfully receive assigned medication
22 Secondary Objectives
The secondary objectives are to evaluate the endpoints include tolerability efficacy and tumor biological response of methylnaltrexone in surgical candidates for OCSCC
23 Exploratory Objectives
The exploratory objectives are to perform tumor RNASeq profiling and assess blood and tumor immunological landscape and to correlate efficacy endpoints with tumor biomarkers
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-2023-10299 | OTHER | NCI-CTRP Clinical Registry | None |