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NCT00853307 · ClinicalTrials.gov registry record · Phase 2

MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

A Phase 2 study, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT00853307: Completed Phase 2 study, sponsored by Millennium Pharmaceuticals.

NCT00853307 is a Phase 2 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00853307, a Phase 2 study, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

Primary Outcome

Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either:

Interventions

  • DRUG Alisertib

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2009-03-23
Est. Completion 2011-01-27
Phase Phase 2
Millennium Pharmaceuticals

135 total trials

What the finished NCT00853307 record still lists

NCT00853307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Alisertib is the first listed.

NCT00853307 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00853307 about?

NCT00853307 is a clinical study titled "MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma". The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

What is the current status of trial NCT00853307?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2009-03-23. Estimated completion is 2011-01-27.

What interventions are being tested in trial NCT00853307?

The interventions under investigation include: Alisertib (DRUG).

Who is sponsoring clinical trial NCT00853307?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00853307's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00853307, the US trial registry maintained by the National Library of Medicine. NCT00853307 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.