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NCT01281254 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Amgen.

Terminated
Registry status
Phase 3
Development phase
223
Enrollment target

NCT01281254: Clinical Trial Phase 3 study, sponsored by Amgen.

NCT01281254 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 223 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01281254, a Phase 3 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 3
Development phase
223 participants
Enrollment target

Study 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.

Interventions

  • DRUG AMG386 plus PLD
  • DRUG Placebo plus PLD

Trial Details

FieldValue
Enrollment Target 223 participants
Start Date 2011-04-18
Est. Completion 2017-04-19
Phase Phase 3
Amgen

558 total trials

Why NCT01281254 stopped before completion

NCT01281254 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 2 interventions - of which AMG386 plus PLD is the first listed.

NCT01281254 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01281254 about?

NCT01281254 is a clinical study titled "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 PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive...

What is the current status of trial NCT01281254?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 223 participants. The study started on 2011-04-18. Estimated completion is 2017-04-19.

What interventions are being tested in trial NCT01281254?

The interventions under investigation include: AMG386 plus PLD (DRUG), Placebo plus PLD (DRUG).

Who is sponsoring clinical trial NCT01281254?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01281254's enrollment target sits among peer trials

223 1317th of 2000 higher than 684 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01281254, the US trial registry maintained by the National Library of Medicine. NCT01281254 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.