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The primary objective is to assess the safety and tolerability of AZD8055 in Japanese patients with advanced solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD8055 | Experimental | AZD8055 will be administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8055 | Drug | Tablets, orally administered, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, coagulation, urinalysis), glucose management (s-glucose, s-insulin, haemoglobin A1c [HbA1c]), vital signs (pulse rate, blood pressure, weight and body temperature) | Laboratory values, vital sign, physical examination every week during Cycle 1 and 2. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetic profile of AZD8055 following both single and multiple oral dosing in patients with advanced solid tumours | According to protocol specified schedule, the number of PK samples collected during Cycle 1 | |
| To seek preliminary evidence of the anti-tumour activity of AZD8055 in patients with advanced solid malignancies as measured by objective tumour response (according to RECIST criteria) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Smith | AstraZeneca | Study Director |
| Tomohide Tamura | National Cancer Center Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22843211 | Derived | Asahina H, Nokihara H, Yamamoto N, Yamada Y, Tamura Y, Honda K, Seki Y, Tanabe Y, Shimada H, Shi X, Tamura T. Safety and tolerability of AZD8055 in Japanese patients with advanced solid tumors; a dose-finding phase I study. Invest New Drugs. 2013 Jun;31(3):677-84. doi: 10.1007/s10637-012-9860-4. Epub 2012 Jul 28. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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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| Every cycle |