advanced solid malignancies
Conditions
Interventions
investigational material(s)
Generic name etc : AZD0530
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Accepts Healthy Volunteers: No -Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists. -World Health Organisation (WHO) performance status 0 to 2. -Life expectancy of at least 12 weeks.
Exclusion criteria
Exclusion criteria: -Inadequate bone marrow reserve. -Inadequate liver function, renal function or low hemoglobin. -Unresolved toxicity from anti-cancer therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test. Time Frame: Assessed on an ongoing basis after starting daily dosing with AZD0530 Designated as safety issue: Yes | — |
Secondary
| Measure | Time frame |
|---|---|
| -To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R Time Frame: 1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days. Designated as safety issue: No | — |
Outcome results
None listed