Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 12:19 AM
Study NCT ID:
NCT00826150
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2009-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer
Sponsor:
Anchiano Therapeutics Israel Ltd.
Organization:
Study Overview
Official Title:
Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2019-05
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 designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma
Detailed Description:
This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP).
Primary Objective: The primary objectives of this study are:
* To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
* To identify any dose limiting toxicities (DLTs).
Secondary Objectives: Secondary objectives of this study are:
* To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
* To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
* To determine the overall survival distribution.
Primary Objective: The primary objectives of this study are:
* To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
* To identify any dose limiting toxicities (DLTs).
Secondary Objectives: Secondary objectives of this study are:
* To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
* To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
* To determine the overall survival distribution.
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?: