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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002519-42 | EudraCT Number |
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Phase I, open study to assess the effect of rifampicin, a marketed drug, on how 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 rifampicin, followed by cediranib alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cediranib | Drug | 45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin | PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of cediranib in the presence of rifampicin, 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 |
|---|---|---|
| Michael Sawyer, MD | Cross Cancer Institute, Edmonton, AB, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada | ||
| Research Site |
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| Label | URL |
|---|---|
| CSR-D8480C00029.pdf | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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|
| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| Research Site | Dundee | DD1 9SY | United Kingdom |
| Research Site | Glasgow | G12 0YN | United Kingdom |
| Research Site | London | NW1 2PG | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| 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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