drugset
drugset / Trial / NCT01133756

E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125

NCT01133756 ↗

Phase 1/2 Terminated 7 enrolled Eisai Inc. PharmaBio Development Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and tolerability of E7080 administered in combination with carboplatin and gemcitabine compared to carboplatin and gemcitabine alone (Phase II) in participants with platinum-sensitive recurrent ovarian cancer.

Timeline

Start
2010-03
Primary completion
2012-02
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 16 mg Oral
Background Carboplatin Small molecule 4 unknown —
Background Gemcitabine Small molecule 1000 mg/m2 —

Indications

ovarian cancer