CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 149 enrolled
Drug / intervention
pertuzumab +3 moredrug
Likely dose
pertuzumab 840 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02004093
NCT02004093Phase 2Completed
CompareCT.gov

A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Hoffmann-La Roche·interventional·Posted Dec 6, 2013·Updated Dec 4, 2014

In Brief

A Phase 2 clinical trial evaluating pertuzumab, paclitaxel, and 2 other interventions for Ovarian Cancer. Completed, enrolled 149 participants across 34 sites in 9 countries.

Detailed Summary

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesBelgium, Canada, Hungary, Italy, Netherlands, Poland, Russia, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 6, 2013
Enrollment StartDec 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.6 years ago

Interventions

pertuzumabdrug

Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks

paclitaxeldrug

175 mg/m2 IV every 3 weeks for 6 cycles

gemcitabinedrug

1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles

carboplatindrug

Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles