A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients
Phase 1
Completed
- Conditions
- CancerTumorsCarcinoma
- Registration Number
- NCT00613652
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
- Patients who usually have mild symptoms capable of walking and light and sedentary work.
- Patients who can stay in hospital at least during 4 weeks.
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Exclusion Criteria
- Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
- Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
- Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies weekly
- Secondary Outcome Measures
Name Time Method To determine the PK profile of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies weekly
Trial Locations
- Locations (1)
Research Site
🇯🇵Fukuoka, Japan