Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00100672|
Recruitment Status : Completed
First Posted : January 5, 2005
Last Update Posted : July 4, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: LErafAON-ETU||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||November 2010|
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of LErafAON-ETU.
- To determine the pharmacokinetics of raf antisense oligonucleotide after intravenous administration of LErafAON-ETU
- To determine any anti-tumor effects of LErafAON-ETU.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100672
|United States, Arizona|
|Scottsdale, Arizona, United States, 85260|
|United States, California|
|Premiere Oncology-Santa Monica|
|Santa Monica, California, United States, 90404|