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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT number 2008-002271-27 |
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Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cediranib (RECENTIN TM, AZD2171) | Drug | 20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole. | PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram. | Until study drug is discountinued |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Roberston | AstraZeneca Aderley Park | Study Director |
| Dr U Lassen, MD PhD | The Finsen Center, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hamilton | Canada | ||||
| Research Site |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C500926 | cediranib |
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|
| Toronto |
| Canada |
| Research Site | Vancouver | Canada |
| Research Site | Copenhagen | Denmark |
| Research Site | Herlev | Denmark |