Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 6:49 AM
Study NCT ID:
NCT02247232
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2014-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Sponsor:
Zeria Pharmaceutical
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial
Status:
COMPLETED
Status Verified Date:
2022-03
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:
This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical cancer on radiotherapy. The study will use a central randomization with a dynamic allocation using biased coin minimization.
Detailed Description:
None
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?: