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A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | oral tablet once daily |
| |
| FOLFOX | Drug | intravenous infusion |
| |
| Pemetrexed | Drug | intravenous infusion |
| |
| Irinotecan (administered with & without Cetuximab) | Drug | intravenous injection |
| |
| Docetaxel | Drug | intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel | After 5 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate. | Assessed at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Robertson | AstraZeneca | Study Director |
| Bijoyesh Mookerjee, MD | AstraZeneca | Study Chair |
| Patricia LoRusso, DO | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ann Arbor | Michigan | United States | |||
| Research Site |
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| Detroit |
| Michigan |
| United States |
| Research Site | Nashville | Tennessee | United States |
| ID | Term |
|---|---|
| C500926 | cediranib |
| C410216 | Folfox protocol |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000068437 | Pemetrexed |
| D000077146 | Irinotecan |
| D000068818 | Cetuximab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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