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TERMINATEDPhase 3NCT01281254

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

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 PL...

Lead sponsor: Amgen•21 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Amgen

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 2, 2017Terms

Trial snapshot

StatusTERMINATED

PhasePHASE3

Enrollment223

Start dateApr 2011

Last updatedDec 2, 2017

Condition

Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cancer

Locations shown

Research Site

Los Angeles, California

Research Site

San Francisco, California

Research Site

Norwalk, Connecticut

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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: May 10, 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.

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