Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005973
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2000-07-05
Brief Title:
BMS-214662 in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 NSC 710086D in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors 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 of BMS-214662 in patients with solid tumors
II Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients
III Determine the nature of dose limiting toxicity of this drug in this patient population
IV Determine the recommended phase II regimen of this drug in these patients V Establish a pharmacologic and pharmacokinetic profile of this drug in these patients
OUTLINE This is a dose escalation study
Patients receive BMS-214662 IV over 1 hour on days 1 8 15 and 22 Treatment repeats every 6 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 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months for at least 24 months
I Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors
II Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients
III Determine the nature of dose limiting toxicity of this drug in this patient population
IV Determine the recommended phase II regimen of this drug in these patients V Establish a pharmacologic and pharmacokinetic profile of this drug in these patients
OUTLINE This is a dose escalation study
Patients receive BMS-214662 IV over 1 hour on days 1 8 15 and 22 Treatment repeats every 6 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 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months for at least 24 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 |
|---|---|---|---|
| ID99-304 | None | None | None |
| U01CA062461 | NIH | None | None |
| CDR0000067960 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |