Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006242
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2000-09-11
Brief Title:
BMS-214662 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Farnesyltransferase Inhibitor BMS-214662 NSC 710086 Escalating to a 24 Hour Continuous Intravenous Infusion in Patients With 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 advanced solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To establish the maximum tolerated dose MTD and identify the dose limiting toxicities DLT of the investigational agent BMS-214662 when escalated to a 24-hour continuous intravenous infusion every 7 days for 3 consecutive weeks to patients with solid tumors who have failed curative or survival prolonging therapy or for who no such therapies exist
II To establish and assess the safety of an appropriate dose for Phase II studies
III To characterize the pharmacokinetics of BMS-214662 in patients when escalated to a 24-hour continuous IV infusion
IV To assess the extent and duration of farnesyltransferase inhibition in peripheral blood mononuclear cells and other relevant surrogate markers of pharmacological activity
SECONDARY OBJECTIVES
I To describe any preliminary evidence of antitumor activity II To establish pharmacodynamic relationships for the pharmacological effect of the drug upon surrogate markers of activity and host toxicity
III To compare the toxicity profiles for the 1 hour IV infusion and 24 hr continuous IV infusion administration schedules assuming that the 24 hr infusion schedule is feasible
OUTLINE This is a dose-prolongation dose-escalation study
Single patient cohorts receive BMS-214662 IV over escalating periods of 2 4 8 16 and 24 hours weekly for 3 weeks followed by 1 week of rest If no patient experiences dose-limiting toxicity DLT dose escalation proceeds in the single patient cohorts
Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Individual patient cohorts may increase their duration of BMS-214662 infusion in subsequent courses to the current duration safely reached
Beginning with the infusion level at which DLT is first encountered by a single patient 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 preceding that at which 2 of 3 or 2 of 6 patients experience DLT An additional cohort of 10 patients is treated at the MTD
Patients are followed for at least 4 weeks
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 9-12 months
I To establish the maximum tolerated dose MTD and identify the dose limiting toxicities DLT of the investigational agent BMS-214662 when escalated to a 24-hour continuous intravenous infusion every 7 days for 3 consecutive weeks to patients with solid tumors who have failed curative or survival prolonging therapy or for who no such therapies exist
II To establish and assess the safety of an appropriate dose for Phase II studies
III To characterize the pharmacokinetics of BMS-214662 in patients when escalated to a 24-hour continuous IV infusion
IV To assess the extent and duration of farnesyltransferase inhibition in peripheral blood mononuclear cells and other relevant surrogate markers of pharmacological activity
SECONDARY OBJECTIVES
I To describe any preliminary evidence of antitumor activity II To establish pharmacodynamic relationships for the pharmacological effect of the drug upon surrogate markers of activity and host toxicity
III To compare the toxicity profiles for the 1 hour IV infusion and 24 hr continuous IV infusion administration schedules assuming that the 24 hr infusion schedule is feasible
OUTLINE This is a dose-prolongation dose-escalation study
Single patient cohorts receive BMS-214662 IV over escalating periods of 2 4 8 16 and 24 hours weekly for 3 weeks followed by 1 week of rest If no patient experiences dose-limiting toxicity DLT dose escalation proceeds in the single patient cohorts
Treatment repeats every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Individual patient cohorts may increase their duration of BMS-214662 infusion in subsequent courses to the current duration safely reached
Beginning with the infusion level at which DLT is first encountered by a single patient 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 preceding that at which 2 of 3 or 2 of 6 patients experience DLT An additional cohort of 10 patients is treated at the MTD
Patients are followed for at least 4 weeks
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 9-12 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 |
|---|---|---|---|
| CDR0000068170 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062490 |
| 00-003 | None | None | None |
| U01CA062490 | NIH | None | None |