NCT00831636

A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Clavis Pharma · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design

Detailed description

Phase I * Three eligible patients will be enrolled at each dose level (DL), according to standard dose escalation decision rules * Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and the recommended dose (RD) have been established Phase II * Step 1 (The patient inclusion may stop after this step): * Patients will be enrolled at the RD until there are maximum 16 evaluable patients at this DL * Step 2: * Depending on the response rate at step 1, up to 26 patients will be included and treated at step 2

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	CP-4055	D1-5 and D8(+2)-12(+2) q4w
DRUG	CP-4055	IV administration day 1-5 and day 8-12 in a 4 week schedule

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2009-01-29
• Last updated: 2013-09-13

Locations

5 sites across 2 countries: Belgium, Italy