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AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT01281254•Amgen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (106)

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Research Site

Norwalk, Connecticut, United States

Research Site

Stamford, Connecticut, United States

Research Site

Orlando, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Evanston, Illinois, United States

Research Site

Saint Louis Park, Minnesota, United States

Research Site

New York, New York, United States

Research Site

Asheville, North Carolina, United States

Key Dates

Start Date

April 18, 2011

Primary Completion Date

August 29, 2014

Completion Date

April 19, 2017

Last Updated

December 2, 2017

Enrollment

223

ACTUAL participants

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cancer

Interventions

AMG386 plus PLD

DRUG

Placebo plus PLD

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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