Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050973
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2002-12-31
Brief Title:
Evaluation of Efficacy Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Randomized Phase III Trial Comparing Targretin CapsulesCisplatinVinorelbine Versus CisplatinVinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2008-07
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:
None
Brief Summary:
This study evaluates the use of Targretin capsules bexarotene in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer NSCLC in patients who have not yet received chemotherapy for their lung cancer
Detailed Description:
This study evaluates the use of Targretin capsules bexarotene in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles approximately four months Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules
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