Advanced Solid Malignancy, Advanced Solid Tumor
Conditions
Sponsors
Astrazeneca K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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)
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety other - | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics other - | — |
Countries
Japan
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed