Ignite Creation Date:
2024-05-05 @ 9:54 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00988208
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2009-10-01
Brief Title:
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer CRPC
Status:
COMPLETED
Status Verified Date:
2018-03
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:
Mainsail
Brief Summary:
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer
The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects
The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects
Detailed Description:
In November 2011 the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival OS and recommended that the study be stopped The study was terminated in accordance with this recommendation All sites were instructed to immediately discontinue all patients from experimental lenalidomideplacebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation Subsequently Protocol Amendment 3 was issued to provide for the following
To continue to collect information on Second Primary Malignancies SPMs and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up
To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomideplacebo and who were experiencing benefit as per investigator discretion For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval an additional two cycles were provided
All references to dosing and study procedures pertaining to the safety efficacy and exploratory endpoints of lenalidomideplacebo were discontinued as part of Protocol Amendment 3
To continue to collect information on Second Primary Malignancies SPMs and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up
To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomideplacebo and who were experiencing benefit as per investigator discretion For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval an additional two cycles were provided
All references to dosing and study procedures pertaining to the safety efficacy and exploratory endpoints of lenalidomideplacebo were discontinued as part of Protocol Amendment 3
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 |
|---|---|---|---|
| EudraCT Number 2008-007969-23 | None | None | None |