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The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1152 | Experimental | AZD1152 treatment given for 2 days every 14 days (2 treatment days followed by 12 days off treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1152 part A | Drug | 48-hour continuous intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (including adverse events detected via laboratory assessment, vital signs and ECG) | Safety and tolerability will be assessed through the incidence of adverse events. Adverse events will include significant findings on vital signs, clinical chemistry/haematology, coagulation parameters and electrocardiograms (ECGs). | Throughout the study. Approximately 9 months for most patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacodynamic biomarker changes | Evaluation of AZD1152 activity in the tumour by assessment of pharmacodynamic biomarker changes which may include, but are not limited to biomarkers of Aurora kinase activity. | Biopsies of tumour at baseline and Cycle 1 [at pre-dose, after Screening to Day 1; and between Days 16-19 (preferrably within 24 hours of completing infusions on Day 17 (Part A) and Day 16 (Part B).] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emerging Oncology Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Boston | Massachusetts | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
| CSR-D1531C00002.pdf | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| AZD1152 part B |
| Drug |
2-hour intravenous infusion |
|
| New York |
| New York |
| United States |