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Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

NCT00849667 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2022-12-30

Study results available
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Summary

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Conditions

Interventions

DRUG

Farletuzumab

Farletuzumab IV infusion.

DRUG

Carboplatin

Carboplatin IV infusion.

DRUG

Taxane

Taxane (Paclitaxel or Docetaxel) IV infusion.

DRUG

Farletuzumab-matched placebo

Farletuzumab-matched placebo IV infusion.

Sponsors & Collaborators

  • Eisai Europe Ltd. (United Kingdom)

    collaborator INDUSTRY

  • Morphotek

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-16
Primary Completion
2012-12-31
Completion
2013-04-12
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

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 NCT00849667 on ClinicalTrials.gov