Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005645
Status:
WITHDRAWN
Last Update Posted:
2018-09-18
First Post:
2000-05-02
Brief Title:
ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage IIIIV Ovarian Cancer
Status:
WITHDRAWN
Status Verified Date:
2001-02
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy
PURPOSE Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the objective response in patients with refractory stage III or IV ovarian epithelial cancer treated with ILX-295501 II Determine the number of patients with at least 50 decrease in CA125 when treated with this regimen III Determine the time to tumor progression overall survival and toxicity profile in this patient population treated with this regimen
OUTLINE This is a multicenter study Patients receive oral ILX-295501 once weekly for 3 weeks Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then every 3 months until death
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive oral ILX-295501 once weekly for 3 weeks Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then every 3 months until death
PROJECTED ACCRUAL A total of 30-50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-9908032 | None | None | None |
| ILEX-295501-211 | None | None | None |
| CND-99-039 | None | None | None |