Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101244
Status:
TERMINATED
Last Update Posted:
2013-01-14
First Post:
2005-01-07
Brief Title:
SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkins or Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Open-Label Dose-Escalation Study of SB-715992 Administered Days 1-3 of a 21-Day Cycle in Patients With Solid Tumors
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively Complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkins or non-Hodgkins lymphoma Drugs used in chemotherapy such as SB-715992 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety and tolerability of SB-715992 administered as a 1-hr intravenous infusion on days 1-3 of a 21-day cycle in patients with solid tumors
II To determine the dose limiting toxicity DLT and maximum tolerated dose MTD of SB-715992 for this administration schedule
SECONDARY OBJECTIVES
I To observe clinical response of SB-715992 given days 1-3 every 21-days II To characterize the pharmacokinetics PK of SB-715992 for this administration schedule
III To explore drug metabolism molecular and cellular predictors of efficacy biomarkers and toxicity and drug interaction potential
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive SB-715992 IV over 1 hour on days 1-3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SB-715992 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 dose-limiting toxicity Up to 10 additional patients are treated at the MTD
Patients are followed for 4 weeks
PROJECTED ACCRUAL A total of 18-31 patients will be accrued for this study within 11-19 months
I To assess the safety and tolerability of SB-715992 administered as a 1-hr intravenous infusion on days 1-3 of a 21-day cycle in patients with solid tumors
II To determine the dose limiting toxicity DLT and maximum tolerated dose MTD of SB-715992 for this administration schedule
SECONDARY OBJECTIVES
I To observe clinical response of SB-715992 given days 1-3 every 21-days II To characterize the pharmacokinetics PK of SB-715992 for this administration schedule
III To explore drug metabolism molecular and cellular predictors of efficacy biomarkers and toxicity and drug interaction potential
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive SB-715992 IV over 1 hour on days 1-3 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SB-715992 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 dose-limiting toxicity Up to 10 additional patients are treated at the MTD
Patients are followed for 4 weeks
PROJECTED ACCRUAL A total of 18-31 patients will be accrued for this study within 11-19 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 |
|---|---|---|---|
| CDR0000404369 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062487 |
| C-2818 | None | None | None |
| U01CA062487 | NIH | None | None |