Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102505
Status:
COMPLETED
Last Update Posted:
2009-04-03
First Post:
2005-01-29
Brief Title:
A Study of Motexafin Gadolinium MGd in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer NSCLC
Sponsor:
Pharmacyclics LLC
Organization:
Pharmacyclics LLC
Study Overview
Official Title:
Phase I Trial of Motexafin Gadolinium MGd in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2009-04
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 purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer
A cycle consists of 3 weeks During week 1 patients receive MGd docetaxel and cisplatin treatment followed by 2 weeks without treatment
Eligible patients will receive 1 or 2 doses of MGd depending on cohort and a single dose of docetaxel and cisplatin at 75 mgm² during the first week of each cycle Additionally tumor response will be evaluated at the end of even numbered cycles 2 4 and 6 Patients may stay on the study a maximum of 6 cycles
A cycle consists of 3 weeks During week 1 patients receive MGd docetaxel and cisplatin treatment followed by 2 weeks without treatment
Eligible patients will receive 1 or 2 doses of MGd depending on cohort and a single dose of docetaxel and cisplatin at 75 mgm² during the first week of each cycle Additionally tumor response will be evaluated at the end of even numbered cycles 2 4 and 6 Patients may stay on the study a maximum of 6 cycles
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