Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004927
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2000-03-07
Brief Title:
BMS-247550 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
Sponsor:
R-Pharm
Organization:
R-Pharm
Study Overview
Official Title:
Phase I Study of BMS-247550 Given Every Three Weeks in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2017-01
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-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of BMS-247550 in treating patients who have advanced solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose dose limiting toxicities safety and a recommended phase II dose of BMS-247550 administered as a 1 hour infusion every 3 weeks in patients with advanced solid tumors II Evaluate the plasma pharmacokinetics of this drug in this patient population III Determine any preliminary evidence of antitumor activity of this drug in these patients
OUTLINE This is a dose escalation study Patients receive BMS-247550 IV over 1 hour every 3 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression 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 3 or 2 of 6 patients experience dose limiting toxicities Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study within 8-12 months
OUTLINE This is a dose escalation study Patients receive BMS-247550 IV over 1 hour every 3 weeks Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression 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 3 or 2 of 6 patients experience dose limiting toxicities Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study within 8-12 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 |
|---|---|---|---|
| MSKCC-99052 | None | None | None |
| CDR0000067611 | REGISTRY | None | None |
| NCI-87 | None | None | None |
| NCI-G00-1698 | None | None | None |
| MAYO-C2072 | Registry Identifier | PDQ Physician Data Query | None |