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| Name | Class |
|---|---|
| Cancer Intelligence Care Systems, Inc. | INDUSTRY |
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The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boron Neutron Capture Therapy (BNCT) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNCT | Radiation | Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours. Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT | Baseline until Day90 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate as assessed by the investigator according to RECISTv1.1 | Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT | Baseline until Day90 |
| Duration of response as assessed by the IRF and the investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Tokyo | Japan |
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From the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first, until confirmed disease progression or death, whichever occurred first |
| Baseline until disease progression or death |
| Time to response as assessed by the IRF | From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first | Baseline until the initial occurrence of CR or PR |
| Complete response (CR) rate as assessed by the IRF and the investigator | Percentage of patients with CR for target lesions after BNCT | Baseline until the initial occurrence of CR |
| Disease control rate as assessed by the IRF and the investigator | Percentage of patients with CR, PR and SD for target lesions after BNCT | Baseline until the initial occurrence of CR, PR or SD |
| Overall response rate as assessed by the IRF and the investigator | Percentage of patients with CR or PR after BNCT | Baseline until the initial occurrence of CR or PR |
| Locoregional progression-free survival as assessed by the investigator | From the date of BNCT until confirmed in-field disease progression | Baseline until in-field disease progression |
| Extra-regional relapse-free survival as assessed by the investigator | From the date of BNCT until confirmed extra-field disease progression (new lesions) | Baseline until extra-field disease progression |
| Progression-free survival as assessed by the IRF and the investigator | From the date of BNCT until confirmed disease progression or death, whichever occurred first | Baseline until disease progression or death |
| Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator | Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT | Baseline until Day90 |
| Overall survival | From the date of BNCT until death from any causes | Baseline until death |