Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129844
Status:
COMPLETED
Last Update Posted:
2008-08-20
First Post:
2005-08-10
Brief Title:
Study of Motexafin Gadolinium MGd for Second Line Treatment of Non-Small-Cell Lung Cancer
Sponsor:
Pharmacyclics LLC
Organization:
Pharmacyclics LLC
Study Overview
Official Title:
Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2008-08
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 this study is to determine the effect of MGd in non-small-cell lung cancer NSCLC when given alone and to evaluate the difference between two dosing regimens
Detailed Description:
Outline
Two-arm open-label randomized 2-stage Phase II trial Patients will be randomized on the first stage to 1 of 2 treatment arms
Arm A - 10 mgkg MGd once per week
Arm B - 15 mgkg MGd once every 3 weeks
Patients will be treated on 3 week cycles up to a maximum of 8 cycles 24 weeks Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy Patients with progressive disease will be terminated from the study
At the end of Stage I both treatment arms will be evaluated and only the arms that demonstrate at least one response Complete Response or Partial Response will proceed to Stage II If both arms demonstrate a response then both will proceed to Stage II
Two-arm open-label randomized 2-stage Phase II trial Patients will be randomized on the first stage to 1 of 2 treatment arms
Arm A - 10 mgkg MGd once per week
Arm B - 15 mgkg MGd once every 3 weeks
Patients will be treated on 3 week cycles up to a maximum of 8 cycles 24 weeks Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy Patients with progressive disease will be terminated from the study
At the end of Stage I both treatment arms will be evaluated and only the arms that demonstrate at least one response Complete Response or Partial Response will proceed to Stage II If both arms demonstrate a response then both will proceed to Stage II
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