Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020371
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-02
Brief Title:
BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BMS-247550 in Patients With Refractory Neoplasms
Status:
COMPLETED
Status Verified Date:
2024-03
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 cancers that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of BMS-247550 in treating patients who have cancers that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose dose-limiting toxic effects and recommended phase II dose of BMS-247550 in patients with refractory neoplasms
II Evaluate the pharmacokinetics and pharmacodynamics of this drug in these patients
III Determine the occurrence of response in patients treated with this drug
PROTOCOL OUTLINE This is a dose-escalation study Patients receive BMS-247550 IV over 1 hour on days 1-5 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 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 at least 2 of 6 patients experience dose-limiting toxicity DLT Once the MTD is determined additional patients are accrued to receive BMS-247550 at the recommended phase II dose
If neutropenia is identified as the DLT a second dose escalation is performed to identify the MTD of BMS-247550 with the addition of filgrastim G-CSF in cohorts as above Patients receive fixed-dose G-CSF 72 hours after final BMS-247550 dose and continuing until blood levels return to normal
PROJECTED ACCRUAL
A total of 45 patients will be accrued for this study within 12-18 months
II Evaluate the pharmacokinetics and pharmacodynamics of this drug in these patients
III Determine the occurrence of response in patients treated with this drug
PROTOCOL OUTLINE This is a dose-escalation study Patients receive BMS-247550 IV over 1 hour on days 1-5 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 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 at least 2 of 6 patients experience dose-limiting toxicity DLT Once the MTD is determined additional patients are accrued to receive BMS-247550 at the recommended phase II dose
If neutropenia is identified as the DLT a second dose escalation is performed to identify the MTD of BMS-247550 with the addition of filgrastim G-CSF in cohorts as above Patients receive fixed-dose G-CSF 72 hours after final BMS-247550 dose and continuing until blood levels return to normal
PROJECTED ACCRUAL
A total of 45 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-550 | None | None | None |
| NCI-00-C-0224 | None | None | None |