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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-575 | Drug | MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign | 30 days after the last dose of MEDI-575 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion | 30 days after last dose of study drug | |
| To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies | 3 months after last dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26223436 | Derived | Murakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000594804 | Tovetumab |
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| Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST) | 3 months after last dose of study drug |
| Kashiwa |
| Chiba |
| Japan |
| Research Site | Matsuyama | Ehime | Japan |
| Research Site | Chuo-ku | Tokyo | Japan |
| Research Site | Sunto-gun | Japan |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |