Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005611
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2000-05-02
Brief Title:
BMS-188797 in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Treatment
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BMS-188797 in Patients With Advanced Malignancies
Status:
UNKNOWN
Status Verified Date:
2000-08
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 I trial to study the effectiveness of BMS-188797 in treating patients who have advanced solid tumors that have not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of BMS-188797 in treating patients who have advanced solid tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and recommended phase II dose dose limiting toxicities and safety of BMS-188787 in patients with nonhematologic malignancies II Determine the plasma pharmacokinetics of BMS-188797 in these patients III Describe any antitumor activity of this treatment in these patients
OUTLINE This is a dose escalation study Patients receive BMS-188797 IV over 1 hour Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of BMS-188797 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 toxicities Patients are followed every 4 weeks until toxicities resolve and then at the investigators discretion
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study over 12-18 months
OUTLINE This is a dose escalation study Patients receive BMS-188797 IV over 1 hour Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of BMS-188797 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 toxicities Patients are followed every 4 weeks until toxicities resolve and then at the investigators discretion
PROJECTED ACCRUAL Approximately 20-40 patients will be accrued for this study over 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-G00-1744 | None | None | None |
| MCC-11836 | None | None | None |
| BMS-CA159-001 | None | None | None |
| MCC-IRB-5140 | None | None | None |