Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024362
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-09-13
Brief Title:
BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of BBR 3464 as First Line Treatment in Patients With Inoperable Locally Advanced or Metastatic Adenocarcinoma of the Pancreas
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of BBR 3464 in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery
PURPOSE Phase II trial to study the effectiveness of BBR 3464 in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery
Detailed Description:
OBJECTIVES I Determine the overall survival of patients with inoperable locally advanced or metastatic adenocarcinoma of the pancreas treated with BBR 3464 II Determine the response rate duration of response time to disease progression and duration of stable disease in patients treated with this drug III Determine the incidence and severity of the toxic effects of this drug in these patients IV Determine the disease-related symptoms in patients treated with this drug
OUTLINE This is a multicenter study Patients receive BBR 3464 IV over 1 hour on day 1 Treatment repeats every 21 days for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 9 weeks
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive BBR 3464 IV over 1 hour on day 1 Treatment repeats every 21 days for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 9 weeks
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| NOVUSPHARMA-TPT-II-06 | None | None | None |
| THERADEX-TPT-II-06 | None | None | None |