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
Phase 1
- Conditions
- Advanced Solid Malignancies
- Registration Number
- JPRN-jRCT2080220492
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 20 Years to 74 Years
Genders Eligible for Study: Both
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
- Not specified
- Primary Outcome Measures
Name Time Method Safety/Efficacy Primary Outcome Measures:The primary objective of this study is to determine the safety and tolerability of AZD2281. [Time Frame: assessed after each visit] [Designated as safety issue: No] Secondary Outcome Measures:The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. [Time Frame: assessed after each visit] [Designated as safety issue: No]
- Secondary Outcome Measures
Name Time Method