Study to Assess the Safety and Tolerability of the Tor Kinase Inhibitor AZD8055
- Registration Number
- NCT00973076
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective
- Relatively good overall health other than cancer
Exclusion Criteria
- Poor bone marrow function (not producing enough blood cells)
- Poor liver or kidney function
- Serious concomitant illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD8055 AZD8055 AZD8055 will be administered orally
- Primary Outcome Measures
Name Time Method Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature) Laboratory values, vital sign, physical examination every week during Cycle 1 and 2.
- Secondary Outcome Measures
Name Time Method To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria) Every cycle To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours According to protocol specified schedule, the number of PK samples collected during Cycle 1
Trial Locations
- Locations (1)
Research Site
🇯🇵Tokyo, Japan