Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285675
Status:
UNKNOWN
Last Update Posted:
2006-05-31
First Post:
2006-01-31
Brief Title:
Study of DN-101 Calcitriol and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Sponsor:
Novacea
Organization:
Novacea
Study Overview
Official Title:
A Continuation Study of DN-101 Calcitriol and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 ASCENT or DN101-004 NSCLC Studies
Detailed Description:
This is a multicenter open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies For subjects enrolled in DN101-002 study only subjects randomized to the DN-101 treatment arm and are currently receiving study drug including subjects on study suspension holiday will be included in the current study For subjects enrolled in DN101-004 study only subjects who are receiving study treatment will be included
Safety will be assessed throughout the study Safety evaluations will consist of a modified physical exam vital signs and weight and laboratory assessments Modified physical exam should be performed at the beginning of each treatment cycle Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle Clinically significant abnormal laboratory values will be reported as adverse events
Safety will be assessed throughout the study Safety evaluations will consist of a modified physical exam vital signs and weight and laboratory assessments Modified physical exam should be performed at the beginning of each treatment cycle Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle Clinically significant abnormal laboratory values will be reported as adverse events
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