A phase II study by using CICS-1 and SPM-011 commissioned by CICS and STELLA PHARMA

JRCT ID: jRCT2031220410

Registered date:26/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable angiosarcoma
• Date of first enrollment: 19/01/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

SPM-011 (JAN:Borofalan (10B)) is administered intravenously at a rate of 200 mg/kg per hour for 2 hours.
The irradiation of the target lesion with neutron beams is then initiated, and SPM-011 is administered intravenously at a rate of 100 mg/kg per hour during irradiation.

Outcome(s)

• Primary Outcome: Response rate (RECIST v1.1)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 89age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hayashi Toshimitsu
• Secondary ID(s): NCT05601232