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

Phase 1 Completed 25 enrolled Genta Incorporated

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2007-05
Primary completion: 2008-03
Completion: 2010-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	oblimersen sodium	Antisense oligonucleotide	300 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	400 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	500 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	600 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	700 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	800 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	900 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	1000 mg	Intravenous
Subject	oblimersen sodium	Antisense oligonucleotide	1100 mg	Intravenous

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

Summary

Timeline

Drugs

Indications