A Phase I Study of G3139 Subcutaneous in Solid Tumors

A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors

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.

Inclusion Criteria:

• 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 chemotherapy

Exclusion Criteria:

• 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
• Pregnancy/Lactation