Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006221
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-09-11
Brief Title:
BMS-247550 in Treating Patients With Advanced Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of BMS-247550 NSC 710428 Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2004-07
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:
Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
IV Determine the antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to prior therapy heavily pretreated vs minimally pretreated
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose level Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course
Patients are followed within 1 month
I Determine the maximum tolerated dose and recommended phase II dose of BMS-247550 in patients with advanced malignancies
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients
IV Determine the antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to prior therapy heavily pretreated vs minimally pretreated
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at that dose level Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course
Patients are followed within 1 month
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-150 | None | None | None |
| UTHSC-IDD-99-32 | None | None | None |
| SACI-IDD-99-32 | None | None | None |