Genasense® is currently administered to subjects in clinical studies as a multiple-day
continuous intravenous infusion. Subjects are treated on an outpatient basis and carry a
pump that delivers the drug through a peripheral or central intravenous line. The route of
administration limits the convenience of treatment, and catheter-related complications have
been reported. This study is designed to evaluate the pharmacokinetics and safety of G3139
administered by subcutaneuous injection.
- A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has
failed standard therapy or for which no standard therapy is available. Patients with
a history of brain metastasis will be eligible if there is no evidence of cerebral
edema or treatment with steroids.
- Adequate organ function as determined < 7 days prior to starting study medication
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- At least 3 weeks and recovery from effects of major prior surgery or other therapy
including radiation therapy, immunotherapy, cytokine, biological, vaccine and
- Significant medical diesese
- History of leptomeningeal disease
- Coexisting condition that would require the subject to continue therapy during the
treatment phase of the study with a drug known to alter renal function.
- Use of any investigational drug within 3 weeks prior to starting study medication
- Known hypersensitivity to phosphorothioate-containing oligonucleotides