NCT00572364

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 20, 2009

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

December 12, 2007

Last Update Submit

August 19, 2009

Conditions

Advanced Solid Malignancies

Keywords

CancerAdvanced solid malignancies

Outcome Measures

Primary Outcomes (1)

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

    assessed after each visit

Secondary Outcomes (1)

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

    assessed after each visit

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)DRUG

oral

Also known as: Olaparib

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 22145984DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

olaparib

Study Officials

  • James Carmichael

    KuDOS/AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

August 20, 2009

Record last verified: 2009-08

Locations

JP(1)