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NCT00494442 · ClinicalTrials.gov registry record · Phase 2

Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target

NCT00494442: Completed Phase 2 study, sponsored by AstraZeneca.

NCT00494442 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00494442, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target

Study Summary

The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.

Primary Outcome

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Interventions

  • DRUG KU-0059436 (AZD2281)(PARP inhibitor)

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2007-06-11
Est. Completion 2017-07-20
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT00494442 record still lists

NCT00494442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 1 intervention - of which KU-0059436 (AZD2281)(PARP inhibitor) is the first listed.

NCT00494442 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00494442 about?

NCT00494442 is a clinical study titled "Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer". The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.

What is the current status of trial NCT00494442?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2007-06-11. Estimated completion is 2017-07-20.

What interventions are being tested in trial NCT00494442?

The interventions under investigation include: KU-0059436 (AZD2281)(PARP inhibitor) (DRUG).

Who is sponsoring clinical trial NCT00494442?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00494442's enrollment target sits among peer trials

58 1135th of 2000 higher than 860 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 NCT00494442, the US trial registry maintained by the National Library of Medicine. NCT00494442 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.