Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100672
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2005-01-04
Brief Title:
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
Phase I Study of an Easy-to-Use Intravenous Formulation of Liposome Entrapped C-raf Antisense Oligonucleotide LErafAON-ETU Administered on a Weekly Schedule in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense Oligonucleotide Easy-to-Use LErafAON-ETU which maximizes potential benefits of the compound to patients with advanced cancer without compromising their safety This study will also assess the processing of LErafAON-ETU by the body over time Patients will receive an intravenous infusion of LErafAON-ETU each week Multiple blood samples will be taken for pharmacokinetic analysis during the first treatment two samples will be taken during both the second and third treatments Patients will be eligible to continue treatment until the occurrence of unacceptable toxicity or disease progression
In LErafAON-ETU antisense oligonucleotides specific to c-raf are associated with liposomes which are microscopic membrane-like structures created from lipids fats Raf-1 is a protein which plays a critical role in many aspects of cellular activation and growth Therefore it is thought to be an important factor that may support tumor development LErafAON-ETU potentially limits the ability of a cell to produce the Raf-1 protein
In LErafAON-ETU antisense oligonucleotides specific to c-raf are associated with liposomes which are microscopic membrane-like structures created from lipids fats Raf-1 is a protein which plays a critical role in many aspects of cellular activation and growth Therefore it is thought to be an important factor that may support tumor development LErafAON-ETU potentially limits the ability of a cell to produce the Raf-1 protein
Detailed Description:
This Phase I open-label dose-escalation study is designed to determine the maximum tolerated dose of LErafAON-ETU in patients who have advanced cancer considered unresponsive to available conventional modalities or treatments LErafAON-ETU will be administered as an IV infusion once weekly for 3 consecutive weeks a Treatment Cycle A complete pharmacokinetic profile of raf-1 antisense oligonucleotide will be assessed in week 1 only limited pharmacokinetic sampling will be done prior to and at the end of infusion in weeks 2 and 3 only Tumordisease evaluation will be performed upon completion of 6 infusions 2 Cycles Dose escalation will not occur until the safety and tolerability at a given dose level has been confirmed for 1 Cycle
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