NCT01538563

Safety of 24-Hour Infusion of ON 01910.Na in Patients With Advanced Cancer

Phase I Dose Escalation Study of ON 01910.Na by 24 Hour Continuous Infusion Per Week in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the highest dose of ON 01910.Na that can be safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to patients with advanced solid tumors.

Detailed description

This is an open-label, dose-escalating Phase I study of ON 01910.Na in patients with advanced cancers, who have satisfied the inclusion/exclusion criteria enumerated in this protocol. Patients will receive ON 01910.Na intravenously by 24 hour continuous infusion once every week (3 weeks per cycle), until evidence of disease progression, intolerable adverse events, or withdrawal of patient consent. Safety monitoring will be done for at least 3 weeks before escalation to the next dose level. As of Amendment 7, up to 6 patients with gynecological malignancies will be enrolled at the 2400 mg/m2 dose level to determine the appropriateness of this dose as the Recommended Phase Two Dose (RPTD).

Conditions

• Solid Tumors
• Advanced Cancer
• Cancer
• Neoplasms

Interventions

Type	Name	Description
DRUG	rigosertib sodium	Patients will receive escalating doses of ON 01910.Na (250 mg/m2 to 4450 mg/m2) intravenously by 24 hour continuous infusion once every week (3 weeks per cycle), until evidence of disease progression, intolerable adverse events, or withdrawal of patient consent.

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-07-01
• Completion: 2011-11-01
• First posted: 2012-02-24
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States