Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004877
Status:
COMPLETED
Last Update Posted:
2009-12-03
First Post:
2000-03-07
Brief Title:
BMS-214662 in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BMS-214662 Oral Dosing in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2009-12
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-214662 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of BMS-214662 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-214662 in patients with advanced solid tumors II Determine the pharmacokinetics of BMS-214662 in these patients III Assess the absolute oral bioavailability of BMS-214662 using a capsule and single intravenous dose in these patients IV Determine any preliminary evidence of antitumor activity of BMS-214662 in these patients
OUTLINE This is a dose escalation study Patients receive BMS-214662 IV over 1 hour on day -7 followed by oral BMS-214662 daily on days 0-14 for course 1 only Beginning with course 2 patients receive oral BMS-214662 twice daily for 14 days Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity Patients are followed every 4 weeks until toxicities resolve
PROJECTED ACCRUAL A total of 30-40 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose escalation study Patients receive BMS-214662 IV over 1 hour on day -7 followed by oral BMS-214662 daily on days 0-14 for course 1 only Beginning with course 2 patients receive oral BMS-214662 twice daily for 14 days Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which fewer than 2 of 6 patients experience dose limiting toxicity Patients are followed every 4 weeks until toxicities resolve
PROJECTED ACCRUAL A total of 30-40 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-G00-1671 | None | None | None |
| MSKCC-99045 | None | None | None |
| BMS-CA158-004 | None | None | None |