drugset / Trial / NCT01165905

Safety of 24-hour Infusion of ON 01910.Na in Combination With Gemcitabine in Advanced Solid Tumors

NCT01165905

Phase 1 Completed 10 enrolled Traws Pharma, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Treatment of cancer is often more effective when two or more drugs are used together. For example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is more inhibition of the growth of the cancer cells compared to either drug used by itself. These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an effective combination in patients can be done, doctors must first know what is largest, safe dose of ON 01910.Na that can be used in combination with gemcitabine and what is the best regimen to use. This study is designed to answer that question.

Timeline

Start
2010-01
Primary completion
2011-07
Completion
2011-07

Publications

  • Results Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

Drugs

EvaluationDrugModalityDoseRoute
Subject rigosertib Small molecule 125 mg/m2 Intravenous
Subject rigosertib Small molecule 250 mg/m2 Intravenous
Subject rigosertib Small molecule 650 mg/m2 Intravenous
Subject rigosertib Small molecule 1050 mg/m2 Intravenous
Subject rigosertib Small molecule 1350 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous

Indications