NCT00572364CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- The primary objective of this study is to determine the safety and tolerability of AZD2281.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The primary objective of this study is to determine the safety and tolerability of AZD2281.
Time Frame: assessed after each visit
Secondary Outcomes
- The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281.(assessed after each visit)
Investigators
Study Sites (1)
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