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

Phase 2

Recruiting

• Conditions: nresectable angiosarcoma

• Registration Number: JPRN-jRCT2031220410
• Lead Sponsor: Hayashi Toshimitsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-26
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified