Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 1:59 AM
Study NCT ID:
NCT01535157
Status:
TERMINATED
Last Update Posted:
2020-08-27
First Post:
2012-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer
Sponsor:
South Plains Oncology Consortium
Organization:
Study Overview
Official Title:
Phase I/II Trial of Fenretinide/LXS Oral Powder (NSC 374551) Plus Ketoconazole in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
drug combination not providing any efficacy. Will use this data in opening new trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of fenretinide (4-HPR/LXS) plus ketoconazole in the treatment of recurrent ovarian cancer or primary peritoneal carcinoma. In addition, researchers would like to determine if the drugs are most effective together or if fenretinide (4-HPR/LXS) is most effective alone.
Detailed Description:
In this study, an initial Phase I component of six patients will be conducted to monitor for potential toxicities as this wil be the initial adult experience of fenretinide (4-HPR) given together with ketoconazole
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?: