Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003430
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
L-778123 in Treating Patients With Recurrent or Refractory Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pharmacokinetic Study Evaluating the Safety Tolerability and Maximally Tolerated Dose of 7-Day Continuous Infusions of L-778123 in Patients With Recurrent of Refractory Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
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 L-778123 in treating patients with recurrent or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of L-778123 in treating patients with recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of L-778123 in patients with recurrent or refractory solid tumors II Evaluate the safety and tolerability of L-778123 including qualitative quantitative and dose limiting toxicity in these patients III Assess the pharmacokinetic profile of this regimen in these patients IV Evaluate the radiologic or tumor marker responses to treatment in these patients V Evaluate the relationship between ras mutations and response to treatment in these patients VI Determine the relationship between plasma drug levels and farnesylation assay results
OUTLINE This is a dose escalation study Patients receive continuous infusions of L-778123 over 7 days every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxic effects All patients are observed for at least 1 week after the 7 day infusion of L-778123 prior to subsequent dose escalation Cohorts of 3-6 patients receive escalating doses of L-778123 until the maximum tolerated dose MTD is reached MTD is defined as the dose at which no more than 2 of 6 patients experiences dose limiting toxicities Patients are followed until death
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive continuous infusions of L-778123 over 7 days every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxic effects All patients are observed for at least 1 week after the 7 day infusion of L-778123 prior to subsequent dose escalation Cohorts of 3-6 patients receive escalating doses of L-778123 until the maximum tolerated dose MTD is reached MTD is defined as the dose at which no more than 2 of 6 patients experiences dose limiting toxicities Patients are followed until death
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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-G98-1453 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066456 | REGISTRY | None | None |
| MERCK-MSKCC-98033 | None | None | None |