Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024492
Status:
COMPLETED
Last Update Posted:
2011-06-06
First Post:
2001-09-17
Brief Title:
Study of Liposome Encapsulated Mitoxantrone LEM in Patients With Advanced Cancer
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Liposome entrapped mitoxantrone LEM is a mixture of commercially available mitoxantrone HCL Novantrone and a combination of lyophilized lipids Mitoxantrone the active agent in the investigational formulation is a currently marketed chemotherapeutic agent The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug which may permit dose intensification andor an increase in the cumulative dose that may be administered resulting in enhanced efficacy
LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability
LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD and dose limiting toxicity DLT of LEM
II Measure the blood pharmacokinetics of LEM following IV administration
III Observe any anti-tumor effects of LEM
PROTOCOL OUTLINE This is an open-label study for patients with advanced andor metastatic histologically-documented solid tumors considered to be unresponsive to available conventional treatment
LEM will be administered IV over 45 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 3-week schedule in the absence of progressive disease or unacceptable toxicity A subsequent course of treatment may be administered at least 21 days after a prior LEM dose has been administered 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
PROJECTED ACCRUAL It is expected that 21 to 30 patients will be entered into the study to determine the MTD 3 per dose level expanded to 6 if DLT occurs followed by a total of 6 patients at a possible MTD The dose level identified as the MTD may then be expanded up to 12 patients to permit additional safety assessment
II Measure the blood pharmacokinetics of LEM following IV administration
III Observe any anti-tumor effects of LEM
PROTOCOL OUTLINE This is an open-label study for patients with advanced andor metastatic histologically-documented solid tumors considered to be unresponsive to available conventional treatment
LEM will be administered IV over 45 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 3-week schedule in the absence of progressive disease or unacceptable toxicity A subsequent course of treatment may be administered at least 21 days after a prior LEM dose has been administered 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
PROJECTED ACCRUAL It is expected that 21 to 30 patients will be entered into the study to determine the MTD 3 per dose level expanded to 6 if DLT occurs followed by a total of 6 patients at a possible MTD The dose level identified as the MTD may then be expanded up to 12 patients to permit additional safety assessment
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