Open Label, Dose Escalation Phase I Study of AZD2281

A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00572364

Enrollment

Registered

2007-12-13

Start date

2007-11-30

Completion date

2009-06-30

Last updated

2009-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies

Keywords

Cancer, Advanced solid malignancies

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

Interventions

DRUGKU-0059436 (AZD2281)(PARP inhibitor)

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

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

* 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.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to determine the safety and tolerability of AZD2281.	assessed after each visit

Secondary

Measure	Time frame
The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281.	assessed after each visit

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026