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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT00636545

Run by

Genta Incorporated

People needed

25

Starts

2007-05-01

Expected to finish

2010-03-01

Last updated by the study team

2012-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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