A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011

Conditions
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Unresectable Angiosarcoma

Intervention / Treatment
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* Radiation: BNCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained from the subject. Histologically documented primary skin angiosarcoma. Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual refuses treatment.) Measurable disease, as defined by RECIST v1.1. The longest diameter of the entire target lesion is 15 cm or less. ECOG performance status score of Grade 0 to 2 Exclusion Criteria: Apparent disseminated tumor lesions. Hereditary fructose intolerance. Phenylketonuria. Any serious concomitant disease that precludes completion of the study treatment. The target lesion has received radiation exceeding 75 Gy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boron Neutron Capture Therapy (BNCT)<br> | Radiation: BNCT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |