Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046540
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2002-09-30
Brief Title:
Liposome Encapsulated SN38 LE-SN38 in Patients With Advanced Cancer
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-06
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:
Liposome Encapsulated SN38 LE-SN38 is an oncology drug product consisting of the active metabolite of irinotecan CPT-11 a known anticancer drug encapsulated in a liposome Formulation of a relatively insoluble compound SN38 and improvement in drug delivery pharmacodynamic profile may be obtained with liposomal formulations An improved safety and efficacy profile compared with the pro-drug CPT-11 may be possible This rationale is supported by the results from animal toxicity studies in both the mouse and dog
LE-SN38 will be infused intravenously every 3 weeks to assess safety and tolerability of study drug until there is disease progression or toxicity requiring early treatment discontinuation Disease status will be assessed after every second cycle of treatment In the event of disease progression study treatment will be discontinued all end-of-treatment study evaluations will be performed and further treatment options will be reviewed
LE-SN38 will be infused intravenously every 3 weeks to assess safety and tolerability of study drug until there is disease progression or toxicity requiring early treatment discontinuation Disease status will be assessed after every second cycle of treatment In the event of disease progression study treatment will be discontinued all end-of-treatment study evaluations will be performed and further treatment options will be reviewed
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose MTD and dose limiting toxicity DLT of LE-SN38
II Determine the plasma pharmacokinetics of SN38 following IV administration of LE-SN38
III Observe any anti-tumor effects of LE-SN38
PROTOCOL OUTLINE
This is an open-label study in patients with advanced solid tumors who have failed conventional therapy
LE-SN38 will be administered IV over 90 minutes At least three patients will be studied at each dose level and at least three patients will complete one 21-day course before any patient is enrolled at the next dose level Study drug administration will continue on an every 21-day schedule in the absence of progressive disease or unacceptable toxicity A subsequent course of treatment may be administered at least 21 days after receiving a prior dose of LE-SN38 when study criteria are met
Cohorts of 3 patients per dose level will be studied This will be expanded to 6 if a DLT occurs followed by a total of 6 patients at a possible MTD
Disease status will be assessed after every second cycle In the event of disease progression study treatment will be discontinued and all end of treatment study evaluations will be performed
PROJECTED ACCRUAL Up to 40 patients will be enrolled
I Determine the maximum tolerated dose MTD and dose limiting toxicity DLT of LE-SN38
II Determine the plasma pharmacokinetics of SN38 following IV administration of LE-SN38
III Observe any anti-tumor effects of LE-SN38
PROTOCOL OUTLINE
This is an open-label study in patients with advanced solid tumors who have failed conventional therapy
LE-SN38 will be administered IV over 90 minutes At least three patients will be studied at each dose level and at least three patients will complete one 21-day course before any patient is enrolled at the next dose level Study drug administration will continue on an every 21-day schedule in the absence of progressive disease or unacceptable toxicity A subsequent course of treatment may be administered at least 21 days after receiving a prior dose of LE-SN38 when study criteria are met
Cohorts of 3 patients per dose level will be studied This will be expanded to 6 if a DLT occurs followed by a total of 6 patients at a possible MTD
Disease status will be assessed after every second cycle In the event of disease progression study treatment will be discontinued and all end of treatment study evaluations will be performed
PROJECTED ACCRUAL Up to 40 patients will be enrolled
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