MedTrace Logo

Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

NCT00718523 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2016-01-12

Study results available
· View outcomes & findings →

Summary

This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (\<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

AMG 479

Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

DRUG

AMG 479 Placebo

Matching placebo administered Day 1 of each 21 day cycle.

Sponsors & Collaborators

  • Translational Research in Oncology

    lead OTHER

Principal Investigators

  • Gottfried E Konecny, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-09-30
Completion
2014-11-30

Countries

  • United States
  • Canada
  • France
  • Germany
  • Ireland
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT00718523 on ClinicalTrials.gov