Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03781986
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2018-12-06
Brief Title:
APG-115 in Salivary Gland Cancer Trial
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Multicenter Phase III Trial of a Novel MDM2 Inhibitor APG-115 in p53 Wild-type Salivary Gland Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment has been placed on hold pending evaluability assessment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III trial to evaluate the efficacy of APG-115 - Carboplatin for the treatment p53 wild-type malignant salivary gland cancer
Part 1 consisted of 2 arms arm A APG-115 monotherapy and arm B APG-115 Carboplatin and was terminated early
Part 2 is a single arm study APG-115 monotherapy
Part 1 consisted of 2 arms arm A APG-115 monotherapy and arm B APG-115 Carboplatin and was terminated early
Part 2 is a single arm study APG-115 monotherapy
Detailed Description:
The current single arm study design was originally part of a study with a parallel arm given combination APG-115 Carboplatin In the initial phase of that previous iteration the combination arm was closed early for issues related to tolerability of the combination therapy This study will continue as a single arm monotherapy alone Phase III study as approved by the UM Institutional Review Board as of June 2021
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 |
|---|---|---|---|
| HUM00155822 | OTHER | University of Michigan IRB | None |
| APG-115SG101 | OTHER | None | None |