Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 1:22 AM
Study NCT ID:
NCT04589832
Status:
TERMINATED
Last Update Posted:
2023-11-22
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
Sponsor:
Arkadiusz Z. Dudek, MD
Organization:
Study Overview
Official Title:
Phase 1B/2 Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study required dose reductions to the lower dose level (Dose level -1). But this dose level (Dose level -1) was not further explored because of lack of funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single arm study with dose escalation Phase Ib cohort followed by a Phase II cohort. PAC-1 (PO) will be given daily on Days 1 through 21 of each cycle (28-day cycle). Entrectinib (PO) will be given daily on Days 1 through 28 of each cycle. Response will be evaluated after every 2 cycles. Treatment will continue until disease progression based on RECIST criteria or intolerable toxicity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: