A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Japanese Patients With Advanced Solid Malignancies
- Conditions
- Advanced Solid Malignancy, Advanced Solid Tumor
- Registration Number
- JPRN-jRCT2080221764
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 41
Aged at least 20 years
- Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST
- World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
- Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
-Dignosis of diabetes mellitus type I or II (irrespective of management)
-Baseline fasting glucose value of 7mmol/l (126mg/dL) or more
-Glycosylated haemoglobin (HbA1C) >6.5%
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
- Inadequate bone marrow reserve or organ function
- Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>other<br>-
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>other<br>-