Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05591560
Status:
UNKNOWN
Last Update Posted:
2022-10-24
First Post:
2022-10-17
Brief Title:
Itraconazole in Advanced Ovarian Cancer
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
The Possible Effect of Itraconazole as add-on Therapy to Paclitaxel and Carboplatin on the Treatment Outcome in Patients With Advanced Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
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 is a randomized placebo controlled parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma stage III and stage IV to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin as regard overall response rate ORR and Disease control rate DCR and Quality of life QOL and the change in the serum concentrations of the biological markers
Detailed Description:
This is a randomized placebo controlled parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma stage III and stage IV The staging of the disease will be done according to 8th edition of American Joint Committee on Cancer AJCC TNM staging The patients will be recruited from Oncology Department Tanta University Hospital The patients will receive a combination of paclitaxel and carboplatin chemotherapy with or without itraconazole Randomization will be carried out based on hospital admission days where the patients will be randomized into the following two groups to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None