Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-02 @ 8:27 AM
Study NCT ID:
NCT01111903
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2010-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse
Sponsor:
ARCAGY/ GINECO GROUP
Organization:
Study Overview
Official Title:
A Two Stage Trial of lénalidomide (Revlimid®) : a Phase II Study of lénalidomide as Single Agent in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse: Followed by a Phase I of lénalidomide in Combination With Carboplatin and Liposomal Pegylated Doxorubicin.
Status:
COMPLETED
Status Verified Date:
2016-03
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:
REV
Brief Summary:
Study in two stages, and with a sub-study.
Detailed Description:
Stage A: To determine efficacy of lenalidomide as single agent in patients with recurrent ovarian cancer in second or third line.
Stage B: To determine the Maximum Tolerated Dose (MTD) of lenalidomide in combination with chemotherapy consisting of carboplatin and pegylated liposomal doxorubicin.
Substudy: To investigate the impact of the lenalidomide on patients' immune system affected by cancer and to look for an immunizing marker which could be predictive of the activity of the lenalidomide in the solid tumors.
Stage B: To determine the Maximum Tolerated Dose (MTD) of lenalidomide in combination with chemotherapy consisting of carboplatin and pegylated liposomal doxorubicin.
Substudy: To investigate the impact of the lenalidomide on patients' immune system affected by cancer and to look for an immunizing marker which could be predictive of the activity of the lenalidomide in the solid tumors.
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?: