Clinical Trials Directory

Trials / Completed

CompletedNCT00034151

Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer

A Phase IIA Evaluation of Safety and Efficacy of Weekly S-8184 Paclitaxel Injectable Emulsion in Second Line Treatment of Stage III or IV Platinum Resistant Ovarian Cancer or Primary Peritoneal Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Achieve Life Sciences · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV platinum resistant ovarian cancer or primary peritoneal carcinoma.

Detailed description

The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Conditions

Interventions

TypeNameDescription
DRUGS-8184 Paclitaxel Injectable Emulsion

Timeline

Start date
2002-03-01
Primary completion
2007-09-01
Completion
2007-09-01
First posted
2002-04-24
Last updated
2009-06-04

Source: ClinicalTrials.gov record NCT00034151. Inclusion in this directory is not an endorsement.