Genasense as a 2-hour Intravenous Infusion in Subjects With Solid Tumors

A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of Genasense Administered as a 2-hour Intravenous Infusion to Subjects With Solid Tumors

The primary objective is to determine the safety and maximum tolerated dose (MTD) of Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly (Part 2) to patients with solid tumors.

Inclusion Criteria:

• Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has failed standard therapy or for which no standard therapy is available
• Adequate organ function as determined ≤ 7 days prior to starting study medication
• Eastern Cooperative Oncology Group performance status 0 to 2
• At least 3 weeks and recovery from effects of major prior surgery or other therapy, including chemotherapy, radiation therapy, immunotherapy, or cytokine, biologic, or vaccine therapy

Exclusion criteria

• Other significant medical disease
• History or presence 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
• Pregnant or lactating