Clinical Trials Directory

Trials / Completed

CompletedNCT00408603

Safety and Efficacy Clinical Study of SNS-595 in Patients With Platinum-Resistant Ovarian Cancer

A Phase 2 Open-Label, Multicenter Study of SNS-595 Injection in Patients With Platinum-Resistant Ovarian Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
183 (actual)
Sponsor
Sunesis Pharmaceuticals · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the objective response rate, safety and identify potential biomarkers in platinum-resistant ovarian cancer patients treated with voreloxin injection given on a 28-day cycle.

Detailed description

Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Conditions

Interventions

TypeNameDescription
DRUGVoreloxin InjectionAll patients in initial dose level receive voreloxin injection at 48 mg/m2 administered once every 21 days up to 6 cycles. Subsequent levels are of 60 mg/m2 or 75 mg/m2 every 28 days up to 6 cycles if safety acceptable.

Timeline

Start date
2006-12-20
Primary completion
2010-06-09
Completion
2010-06-09
First posted
2006-12-07
Last updated
2017-07-27
Results posted
2017-06-28

Locations

20 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT00408603. Inclusion in this directory is not an endorsement.