Open Label, Dose Escalation Phase I Study of AZD2281

Phase 1

Completed

• Conditions: Advanced Solid Malignancies

• Registration Number: NCT00572364
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-19
• Last Update Posted: 2009-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan