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Some of the raw materials for the investigational drug are difficult to obtain and expensive.
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The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Study Arm, no competitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTSA101-DTPA-111In | Drug | single IV injection, 185MBq/body |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In | Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed. | up to 72 hours post dosing |
| Safety of OTSA101-DTPA-111In | This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria. | up to 10 days post dosing |
| Safety of OTSA101-DTPA-90Y | This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria. | up to 6 weeks post dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka International Cancer Institute | Osaka | Japan | ||||
| Cancer Institute Hospital of JFCR |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D013584 | Sarcoma, Synovial |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009372 | Neoplasms, Connective Tissue |
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| OTSA101-DTPA-90Y |
| Drug |
IV injection (max. 3 injections per patient), 1110MBq/body |
|
| Tokyo |
| Japan |
| National Cancer Center Hospital | Tokyo | Japan |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |