Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003705
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
1999-11-01
Brief Title:
BMS-184476 in Treating Patients With Advanced Solid Tumors
Sponsor:
San Antonio Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BMS-184476 in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2007-08
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of BMS-184476 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose dose limiting toxicity recommended phase II dose and safety of BMS-184476 in patients with advanced solid tumors II Determine the pharmacokinetic profile of BMS-184476 and its metabolites in these patients III Determine preliminary evidence of antitumor activity of BMS-184476 in these patients
OUTLINE This is an open label dose escalation study Patients receive BMS-184476 IV over 1 hour Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity In the second part of the study patients receive BMS-184476 IV over 1 hour weekly Cohorts of 3-6 patients are treated at escalating doses of BMS-184476 The maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity Patients are followed every 4 weeks until toxicity is resolved
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 12-18 months
OUTLINE This is an open label dose escalation study Patients receive BMS-184476 IV over 1 hour Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity In the second part of the study patients receive BMS-184476 IV over 1 hour weekly Cohorts of 3-6 patients are treated at escalating doses of BMS-184476 The maximum tolerated dose is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity Patients are followed every 4 weeks until toxicity is resolved
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| NCI-V98-1499 | None | None | None |
| UTHSC-9785011072 | None | None | None |
| BMS-CA154-001 | None | None | None |
| SACI-IDD-97-21 | None | None | None |