Safety of ON 01910.Na as a 3-day Infusion in Patients With Advanced Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

October 31, 2010

Study Completion Date

January 31, 2012

Conditions
Advanced CancerSolid TumorsCancerNeoplasms
Interventions
DRUG

rigosertib sodium

ON 01910.Na will be supplied as a sterile, concentrated solution (75 mg/ml) in labeled, sealed glass vials. ON 01910.Na concentrated solution (75 mg/ml) must be diluted before intravenous administration. The starting dose will be 50 mg/m2 over 24 hour infusion daily for 3 days. A fresh infusion must be prepared for each day of the 3-day continuous infusion. This 3-day continuous treatment followed by 11 days without administration of study drug will constitute 1 Cycle. Cycles can be repeated every 2 weeks. The dosing of ON 01910.Na will be based on body surface area (BSA). In the absence of toxicity that would cause accelerated dose escalation to cease, drug doses are planned to escalate every 3 weeks.

Trial Locations (1)

10029

Mount Sinai School of Medicine, New York

All Listed Sponsors
lead

Traws Pharma, Inc.

INDUSTRY

NCT01538537 - Safety of ON 01910.Na as a 3-day Infusion in Patients With Advanced Cancer | Biotech Hunter | Biotech Hunter