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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 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-06-22

Study results available
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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.

Conditions

Interventions

DRUG

Lenvatinib

lenvatinib (as 1mg, 4mg, and 10mg tablets) was administered orally, once daily continuously for each 21-day treatment cycle.

DRUG

Carboplatin

Carboplatin was to be administered on Day 1 of every 21-day cycle at a dose AUC 4 over 30 minutes.

DRUG

Gemcitabine

Gemcitabine was to be administered on Day 1 and Day 8 of every 21-day cycle at a dose of 1000 mg/m2 over 30 minutes.

Sponsors & Collaborators

  • PharmaBio Development Inc.

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Harish Dave, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-02-29
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01133756 on ClinicalTrials.gov