Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373204
Status:
TERMINATED
Last Update Posted:
2014-07-24
First Post:
2006-09-05
Brief Title:
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel Taxotere
Sponsor:
Pharmacyclics LLC
Organization:
Pharmacyclics LLC
Study Overview
Official Title:
Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2014-07
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:
The purpose of this study is to determine if the addition of motexafin gadolinium study drug to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer
Detailed Description:
Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone In this trial patients will receive 10 mgkg MGd followed by 75 mgm2 once every 3 weeks This dosing regimen was well tolerated in the Phase I dose escalation trial A Simon 2-stage trial design will be used if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response the study will proceed to Stage 2 where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1 Patients with stable disease CR or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD death or end of study
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