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The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how hepatocellular carcinoma responds to the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD8055 | Experimental | Dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8055 | Drug | Dose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination) | Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards | |
| Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing | Blood samples on 6 occasions during the first Cycle of the study (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| To make a preliminary assessment of efficacy | Every 4 weeks | |
| To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment. | During Cycle 1 of the study - blood samples before study treatment and then on Day 1, 3, 10, 17, 24, 30 and then on day 1 of every cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigette Ma | Prince of Wales Hospital, HongKong | Principal Investigator |
| Ian Smith | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hong Kong | Hong Kong | ||||
| Research Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C546624 | (5-(2,4-bis((3S)-3-methylmorpholin-4-yl)pyrido(2,3-d)pyrimidin-7-yl)-2-methoxyphenyl)methanol |
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|
| Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055 | Blood samples x 3 times on Day 1 of the first cycle |
| To collect and store DNA for future exploratory research that may influence response to AZD8055 | May not be reported in the CSR | Blood sample on Day 1 or at any other visit during study |
| Seongnam-si |
| Gyeonggi-do |
| South Korea |
| Research Site | Seoul | South Korea |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |