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

Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01538563
Study type Interventional
Source Onconova Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date June 2006
Completion date November 2011
View Details
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