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TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

NCT01493505 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1015

Last updated 2017-02-23

No results posted yet for this study

Summary

The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.

Conditions

Interventions

DRUG

AMG 386

AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)

DRUG

Paclitaxel

Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)

DRUG

AMG 386 Placebo

AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)

DRUG

Carboplatin

Carboplatin AUC 5 or 6 IV Q3W (6 cycles)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-03-31
Completion
2016-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Germany
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01493505 on ClinicalTrials.gov