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A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer

NCT02289950 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2021-09-02

Study results available
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Summary

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.

Conditions

  • Platinum-Sensitive Ovarian Cancer in First Relapse

Interventions

DRUG

Farletuzumab

Farletuzumab will be administered intravenously (IV) weekly

DRUG

Placebo

Placebo will be administered intravenously (IV) weekly

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-19
Primary Completion
2019-05-31
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Italy
  • Japan
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02289950 on ClinicalTrials.gov