AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

November 27, 2017 updated by: Amgen

A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • Research Site
      • Wahroonga, New South Wales, Australia, 2076
        • Research Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Research Site
      • Greenslopes, Queensland, Australia, 4120
        • Research Site
    • Victoria
      • East Bentleigh, Victoria, Australia, 3165
        • Research Site
      • Footscray, Victoria, Australia, 3011
        • Research Site
      • Malvern, Victoria, Australia, 3144
        • Research Site
      • Parkville, Victoria, Australia, 3052
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Graz, Austria, 8020
        • Research Site
      • Innsbruck, Austria, 6020
        • Research Site
      • Linz, Austria, 4010
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Wien, Austria, 1160
        • Research Site
  • Belgium
      • Charleroi, Belgium, 6000
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Ieper, Belgium, 8900
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Libramont, Belgium, 6800
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Namur, Belgium, 5000
        • Research Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
  • Denmark
      • Herlev, Denmark, 2730
        • Research Site
      • København, Denmark, 2100
        • Research Site
  • France
      • Amiens, France, 80000
        • Research Site
      • Avignon cedex 9, France, 84918
        • Research Site
      • Lyon cedex 8, France, 69373
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Saint Cloud, France, 92210
        • Research Site
  • Germany
      • Berlin, Germany, 13353
        • Research Site
      • Bonn, Germany, 53105
        • Research Site
      • Düsseldorf, Germany, 40217
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Essen, Germany, 45136
        • Research Site
      • Frankfurt am Main, Germany, 60590
        • Research Site
      • Freiburg, Germany, 79106
        • Research Site
      • Hannover, Germany, 30177
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • München, Germany, 81675
        • Research Site
      • München, Germany, 81377
        • Research Site
      • Rostock, Germany, 18059
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • New Territories, Hong Kong
        • Research Site
  • Hungary
      • Budapest, Hungary, 1062
        • Research Site
      • Budapest, Hungary, 1032
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Miskolc, Hungary, 3526
        • Research Site
      • Szeged, Hungary, 6720
        • Research Site
      • Zalaegerszeg - Pozva, Hungary, 8900
        • Research Site
  • Italy
      • Campobasso, Italy, 86100
        • Research Site
      • Genova, Italy, 16128
        • Research Site
      • Milano, Italy, 20141
        • Research Site
      • Milano, Italy, 20133
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Roma, Italy, 00168
        • Research Site
      • Roma, Italy, 00128
        • Research Site
      • Roma, Italy, 00161
        • Research Site
  • New Zealand
      • Grafton, Auckland, New Zealand, 1023
        • Research Site
      • Tauranga, New Zealand, 3143
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Gdansk, Poland, 80-219
        • Research Site
  • Singapore
      • Singapore, Singapore, 169610
        • Research Site
      • Singapore, Singapore, 229899
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 812 50
        • Research Site
      • Bratislava, Slovakia, 831 01
        • Research Site
      • Kosice, Slovakia, 041 91
        • Research Site
      • Presov, Slovakia, 080 01
        • Research Site
  • Switzerland
      • Aarau, Switzerland, 5001
        • Research Site
      • Chur, Switzerland, 7000
        • Research Site
      • Geneva 14, Switzerland, 1211
        • Research Site
      • Zurich, Switzerland, 8091
        • Research Site
  • Taiwan
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei, Taiwan, 10041
        • Research Site
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Poole, United Kingdom, BH15 2JB
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Research Site
      • San Francisco, California, United States, 94143
        • Research Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Research Site
      • Stamford, Connecticut, United States, 06902
        • Research Site
    • Florida
      • Orlando, Florida, United States, 32806
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Research Site
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Research Site
    • New York
      • New York, New York, United States, 10029
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Research Site
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Research Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Research Site
      • Milwaukee, Wisconsin, United States, 53215
        • Research Site
      • West Allis, Wisconsin, United States, 53227
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Female 18 years of age or older at the time the written informed consent is obtained
  • Adequate organ and hematological function

Exclusion Criteria:

  • Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
  • Subjects with primary platinum-refractory disease
  • Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
  • History of central nervous system metastasis
  • Major surgery within 28 days prior to randomization or still recovering from prior surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo plus PLD
Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Drug: Placebo plus PLD

Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.

PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
Experimental: AMG386 plus PLD
Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
Drug: AMG386 plus PLD
AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications
Time Frame: Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.
Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.

Secondary Outcome Measures

Outcome Measure
Time Frame
• To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2011

Primary Completion (Actual)

August 29, 2014

Study Completion (Actual)

April 19, 2017

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 21, 2011

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060517 (Other Identifier: Amgen. Inc.)
  • 2009-017946-30 (EudraCT Number)
  • ENGOT-ov-6
  • TRINOVA-2 (Other Identifier: Amgen, Inc)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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