Open Label, Dose Escalation Phase I Study of AZD2281

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572364

D0810C00001

Details and patient eligibility

About

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

Enrollment: 18 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)