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CompletedNCT00572364Updated Aug 20, 2009

Open Label, Dose Escalation Phase I Study of AZD2281

A Phase 1 interventional study of KU-0059436 (AZD2281)(PARP inhibitor) in Advanced Solid Malignancies, sponsored by AstraZeneca. Completed at 1 site in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2009-08-20.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
20 Years to 74 Years
Sex
All
01

Study summary

The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies

02

Conditions studied

  • Advanced Solid Malignancies

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Keywords

  • Cancer
  • Advanced solid malignancies
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 18 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion criteria

Exclusion Criteria:

  • Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Interventions

  • DrugKU-0059436 (AZD2281)(PARP inhibitor)

    oral

    Also known as: Olaparib

06

What researchers measure

Primary outcomes

  1. The primary objective of this study is to determine the safety and tolerability of AZD2281.

    Time frame: assessed after each visit

Secondary outcomes

  1. The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281.

    Time frame: assessed after each visit

07

Study locations

1 site
  • Research Site
    Tokyo, Japan
08

References and documents

Publications

  • Yamamoto N, Nokihara H, Yamada Y, Goto Y, Tanioka M, Shibata T, Yamada K, Asahina H, Kawata T, Shi X, Tamura T. A Phase I, dose-finding and pharmacokinetic study of olaparib (AZD2281) in Japanese patients with advanced solid tumors. Cancer Sci. 2012 Mar;103(3):504-9. doi: 10.1111/j.1349-7006.2011.02179.x. Epub 2012 Jan 30. PubMed 22145984 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00572364
Lead sponsor
AstraZeneca
First posted
Dec 13, 2007
Start date
Nov 2007
Primary completion
Mar 2009
Completion
Jun 2009
Last update
Aug 20, 2009

Study contacts

James Carmichael
study director · KuDOS/AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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