Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient
- Registration Number
- NCT01213160
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.
- Detailed Description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients with Advanced Solid Malignancies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer
Exclusion Criteria
- Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD4547 AZD4547 -
- Primary Outcome Measures
Name Time Method Assessment of adverse events (based on CTCAE version 4.0), LVEF LVEF on day 21 in cycle 1. Assessment of adverse events (based on CTCAE version 4.0), eye examination Eye examination on day 21 in cycle 1. Assessment of adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0)general examination General examination prior to IP administration in treatment cycles Assessment of adverse events (based on CTCAE version 4.0), laboratory values Laboratory assessment day 21 cycle 1. Assessment of adverse events (based on CTCAE version 4.0), vital sign measurements Vital sign measurements day 21 in cycle 1. Assessment of adverse events (based on CTCAE version 4.0), left ventricular ejection fraction (LVEF) LVEF prior to study administration Assessment of adverse events (based on CTCAE version 4.0)general examination General examination day 21 in cycle 1.
- Secondary Outcome Measures
Name Time Method Define the maximum tolerated dose (MTD) if possible or biological effective dose. Up to 3 weeks To explore the pharmacokinetics (PK) of AZD4547and metabolite in Japanese patients with advanced solid malignancies when given AZD4547 orally. Schedule of PK assessment 1. AZD4547; blood Cycle0-day1 -day21; 27 point 2. AZD4547 metabolite; blood Cycle1-day21; 1 poin 3. AZD4547; urine Cycle1-day21; 1 point To obtain a preliminary assessment of the anti-tumour effect of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. Schedule of CT/MRI etc-screeing-cycle1 day21-every 6 weeks-the end of treatment
Trial Locations
- Locations (1)
Research Site
🇯🇵Sapporo-shi, Japan