drugset / Trial / NCT00409383

Abraxane and Temodar Plus Genasense in Advanced Melanoma

NCT00409383

Phase 1 Unknown 28 enrolled Genta Incorporated
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).

Timeline

Start
2006-11
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Temozolomide Small molecule 75 mg/m2 Oral
Subject oblimersen sodium Antisense oligonucleotide 7 mg/kg Intravenous
Subject oblimersen sodium Antisense oligonucleotide 900 mg Intravenous

Indications