Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273338
Status:
TERMINATED
Last Update Posted:
2007-11-06
First Post:
2005-12-14
Brief Title:
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer AIPC AIPC Study of Calcitriol Enhancing Taxotere ASCENT-2
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Phase 3 Randomized Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer AIPC ASCENT-2
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is
To evaluate the effect of DN-101 in combination with docetaxel ASCENT regimen on survival in metastatic androgen-independent prostate cancer
The secondary objectives of this study are
To determine the effect of the ASCENT regimen on the rate of thromboembolic events blood clots
To determine the effect of the ASCENT regimen on prevention of skeletal-related events fractures
A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101
To evaluate the effect of DN-101 in combination with docetaxel ASCENT regimen on survival in metastatic androgen-independent prostate cancer
The secondary objectives of this study are
To determine the effect of the ASCENT regimen on the rate of thromboembolic events blood clots
To determine the effect of the ASCENT regimen on prevention of skeletal-related events fractures
A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101
Detailed Description:
None
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