July. 31, 2024 |
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Dec. 09, 2024 |
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jRCT2031240246 |
Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment (SJ-BT001) |
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Phase I/II basket trial: Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for patients with recurrent solid malignant thoracic tumors that are unresectable and perceived challenging to treat with standard treatment |
Hayashi Toshimitsu |
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STELLA PHARMA CORPORATION |
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ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka |
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+81-6-4707-1516 |
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sp-chiken@stella-pharma.co.jp |
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Clinical trials information |
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Stella Pharma Corporation |
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ORIX Kouraibashi Building, 3-2-7 Kouraibashi, Chuo-ku, Osaka |
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+81-647071516 |
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sp-chiken@stella-pharma.co.jp |
Pending |
Mar. 01, 2025 |
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30 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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- Written informed consent must be obtained from the subject. |
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- Patients with active disease or active double cancers other than target lesions. |
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18age old over | ||
85age old under | ||
Both |
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Thoracic solid malignant tumor |
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- Intravenous administration of investigational drug. |
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- Occurrence rate of dose-limiting toxicity |
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Stella Pharma Corporation |
Cancer Intelligence Care Systems, Inc. |
Sumitomo Heavy Industries, Ltd. |
National Cancer Center Institutional Review Board | |
5-1-1 Tsukiji, Chuo-ku, Tokyo, Tokyo, Tokyo | |
+81-3-3542-2511 |
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Chiken_CT@ml.res.ncc.go.jp | |
Approval | |
Aug. 28, 2024 |
No |
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none |