Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004199
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2000-01-21
Brief Title:
Prinomastat and Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Non-small Cell Lung Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat AG3340 in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE Prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the overall survival progression free survival symptomatic progression free survival and one year survival of patients with metastatic or recurrent non-small cell lung cancer treated with prinomastat AG3340 or placebo in combination with gemcitabine and cisplatin II Compare the disease response and duration of response in these patients on these regimens III Compare the quality of life of these patients on these regimens IV Evaluate the safety of these regimens in these patients
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients receive oral prinomastat or placebo twice daily beginning on day 1 followed by gemcitabine IV on days 1 and 8 and cisplatin IV on day 1 Courses repeat every 3 weeks
PROJECTED ACCRUAL Approximately 420 patients will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients receive oral prinomastat or placebo twice daily beginning on day 1 followed by gemcitabine IV on days 1 and 8 and cisplatin IV on day 1 Courses repeat every 3 weeks
PROJECTED ACCRUAL Approximately 420 patients will be accrued for this 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067442 | None | None | None |