Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003891
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2000-06-02
Brief Title:
Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of NX211 Given as an IV Infusion Days 1 2 and 3 Every 3 Weeks in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2020-04
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 lurtotecan liposome in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of lurtotecan liposome in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD and the future dose of lurtotecan liposome in patients with advanced solid tumors II Assess the toxicity and pharmacokinetics of this treatment regimen in this patient population III Assess the response to this regimen by patients with measurable disease
OUTLINE This is a dose escalation multicenter study Patients receive lurtotecan liposome NX211 IV over 30 minutes on days 1 2 and 3 Courses are repeated every 3 weeks Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed at 4 weeks and every 3 months for 1 year
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study within 12-15 months
OUTLINE This is a dose escalation multicenter study Patients receive lurtotecan liposome NX211 IV over 30 minutes on days 1 2 and 3 Courses are repeated every 3 weeks Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed at 4 weeks and every 3 months for 1 year
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study within 12-15 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000067060 | OTHER | PDQ | None |
| CAN-NCIC-IND123 | OTHER | None | None |
| NEXSTAR-110-02 | OTHER | None | None |