Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT02950103
Status:
TERMINATED
Last Update Posted:
2019-09-30
First Post:
2016-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients
Sponsor:
Secretaria de Estado da Saúde
Organization:
Study Overview
Official Title:
Efficacy and Safety Evaluation of Synthetic Phosphoethanolamine in Solid Tumor Patients
Status:
TERMINATED
Status Verified Date:
2019-09
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:
Synthetic phosphoethanolamine is a primary amine which has a critical role in the biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.
Detailed Description:
Phase II multi-cohort study based on two-stage Simon design. The primary goal of the study is response rate at 8 weeks in participants with advanced solid tumors treated with synthetic phosphoethanolamine, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) or specific criteria for prostate cancer.
Study Oversight
Has Oversight DMC:
True
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?: