Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
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.