Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190840
Status:
COMPLETED
Last Update Posted:
2007-01-26
First Post:
2005-09-12
Brief Title:
A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2007-01
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:
In previous phase 2 studies pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin Since the introduction of vitamin supplementation pemetrexed has shown good tolerance and high safety Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing as has been demonstrated by a recent Phase 1 study The higher dose with supplementation may increase pemetrexeds efficacy without unduly compromising safety The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H3E-AA-S037 | None | None | None |