Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321308
Status:
TERMINATED
Last Update Posted:
2009-09-28
First Post:
2006-05-02
Brief Title:
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Phase II Trial Of Pemetrexed With Or Without PF-3512676 For The Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of One Prior Chemotherapy Regimen For Advanced Disease
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See Termination Reason in Detailed Description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
Detailed Description:
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy citing lack of efficacy concerns as the primary reason with safety issues sepsis thrombocytopenia also contributing to the decision Subjects were allowed to complete standard of care treatment and protocol follow-up Data collection was completed on 31 January 2008
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