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TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

NCT01204749 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 919

Last updated 2016-12-15

No results posted yet for this study

Summary

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Conditions

Interventions

DRUG

AMG 386

Weekly Intravenous (IV) AMG 386 15 mg/kg

DRUG

AMG 386 Placebo

Weekly Intravenous (IV) placebo 15 mg/kg

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)

DRUG

Paclitaxel

Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-03-31
Completion
2016-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Czechia
  • Estonia
  • France
  • Greece
  • Hong Kong
  • India
  • Israel
  • Italy
  • Japan
  • Latvia
  • Malaysia
  • Mexico
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT01204749 on ClinicalTrials.gov