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NCT01078662 · ClinicalTrials.gov registry record · Phase 2

Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
298
Enrollment target

NCT01078662: Completed Phase 2 study, sponsored by AstraZeneca.

NCT01078662 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 298 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01078662, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
298 participants
Enrollment target

Study Summary

To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Primary Outcome

Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).

Interventions

  • DRUG olaparib

Trial Details

FieldValue
Enrollment Target 298 participants
Start Date 2010-02-21
Est. Completion 2024-08-12
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT01078662 record still lists

NCT01078662 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher).

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

NCT01078662 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01078662 about?

NCT01078662 is a clinical study titled "Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats". To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

What is the current status of trial NCT01078662?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 298 participants. The study started on 2010-02-21. Estimated completion is 2024-08-12.

What interventions are being tested in trial NCT01078662?

The interventions under investigation include: olaparib (DRUG).

Who is sponsoring clinical trial NCT01078662?

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 NCT01078662's enrollment target sits among peer trials

298 188th of 2000 higher than 1,813 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 NCT01078662, the US trial registry maintained by the National Library of Medicine. NCT01078662 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.