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This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD0530 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0530 | Drug | oral, tablet, once daily, dose will be variable |
|
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Stuart, MD | AstraZeneca | Study Chair |
| Narikazu Boku, MD | Saint Marianna University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Takatsuk | Osaka | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22415795 | Derived | Fujisaka Y, Onozawa Y, Kurata T, Yasui H, Goto I, Yamazaki K, Machida N, Watanabe J, Shimada H, Shi X, Boku N. First report of the safety, tolerability, and pharmacokinetics of the Src kinase inhibitor saracatinib (AZD0530) in Japanese patients with advanced solid tumours. Invest New Drugs. 2013 Feb;31(1):108-14. doi: 10.1007/s10637-012-9809-7. Epub 2012 Mar 14. |
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| ID | Term |
|---|---|
| C515233 | saracatinib |
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| Tumor response | at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks. |
| Sunto-gun |
| Shizuoka |
| Japan |