Solid Tumor
Conditions
Keywords
Advanced carcinoma
Brief summary
This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.
Interventions
DRUGAZD0530
oral, tablet, once daily, dose will be variable
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
* 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. | Assessed on an ongoing basis after starting daily dosing with AZD0530 |
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 | 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. |
| Tumor response | at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks. |
Countries
Japan
Outcome results
None listed