Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00179712
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2005-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
Sponsor:
Celgene Corporation
Organization:
Study Overview
Official Title:
Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid®) With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: