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This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.
The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | cediranib 20mg |
|
| 2 | Experimental | cediranib 30mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cediranib (RECENTIN TM, AZD2171) | Drug | 20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of single dose of cediranib 20mg or 30 mg by assessment of area under the curve over the time (AUC) and maximum concentration in Chinese patients with advanced solid malignant tumours | Multiple assessments in the first 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignant tumours | Multiple assessments up to day 29 | |
| To assess the safety and tolerability of single and multiple doses of cediranib 20mg or 30 mg in Chinese patients with advanced solid malignancies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannie Hou | AstraZeneca China MC | Study Director |
| Sun Yan, Prof | Cancer Hospital, CAMS&PUMC, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
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| ID | Term |
|---|---|
| C500926 | cediranib |
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| Safety assessments to be taken until Day 29 (while patient remains on study treatment), then every 4 weeks until treatment discontinuation and then 30 day follow up |
| Hong Kong |
| Hong Kong |
| China |