Open Label, Dose Escalation Phase I Study of AZD2281

Advanced Solid Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572364
• Other study ID #: D0810C00001
• Status: Completed
• Phase: Phase 1
• First received: December 12, 2007
• Last updated: August 19, 2009
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

Drug:
• KU-0059436 (AZD2281)(PARP inhibitor)
oral

Locations

Country	Name	City	State
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to determine the safety and tolerability of AZD2281.		assessed after each visit	No
Secondary	The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281.		assessed after each visit	No