Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042679
Status:
COMPLETED
Last Update Posted:
2006-07-19
First Post:
2002-08-02
Brief Title:
A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha LY900003 ISIS 3521 Plus Gemcitabine and Carboplatin in Patients With Advanced Previously Untreated Non-Small Cell Lung Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha LY900003 ISIS 3521 Plus Gemcitabine and Carboplatin in Patients With Advanced Previously Untreated Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-07
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:
The purposes of this study are to determine the following
Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear and for how long
If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer
The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs
How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine
Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body
Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear and for how long
If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer
The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs
How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine
Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body
Detailed Description:
Definition The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin LY900003 will be given at approximately 2 mgkgday for the first 14 days of a 21-day cycle The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003 Gemcitabine will be administered on Days 1 and 8 at 1250 mgm2 and carboplatin will be given on Day 1 at AUC 5
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 |
|---|---|---|---|
| H7X-MC-JVAB | None | None | None |