Back to resultsA Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
Primary Purpose
Unresectable Angiosarcoma
Status
Recruiting
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
BNCT
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Angiosarcoma
Eligibility Criteria
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. Measurable disease, as defined by RECIST v1.1. Exclusion Criteria: Apparent disseminated tumor lesions. Hereditary fructose intolerance. Phenylketonuria. Any serious concomitant disease that precludes completion of the study treatment.
Sites / Locations
- National Cancer Center HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Boron Neutron Capture Therapy (BNCT)
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Complete response (CR) rate as assessed by the IRF and the investigator
Percentage of patients with CR for target lesions after BNCT
Disease control rate as assessed by the IRF and the investigator
Percentage of patients with CR, PR and SD for target lesions after BNCT
Overall response rate as assessed by the IRF and the investigator
Percentage of patients with CR or PR after BNCT
Locoregional progression-free survival as assessed by the investigator
From the date of BNCT until confirmed 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)
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
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
Overall survival
From the date of BNCT until death from any causes
Full Information
NCT ID
NCT05601232
First Posted
October 27, 2022
Last Updated
November 21, 2022
Sponsor
Stella Pharma Corporation
Collaborators
Cancer Intelligence Care Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05601232
Brief Title
A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
Official Title
A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stella Pharma Corporation
Collaborators
Cancer Intelligence Care Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Angiosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Boron Neutron Capture Therapy (BNCT)
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
BNCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
Time Frame
Baseline until Day90
Secondary Outcome Measure Information:
Title
Response rate as assessed by the investigator according to RECISTv1.1
Description
Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT
Time Frame
Baseline until Day90
Title
Duration of response as assessed by the IRF and the investigator
Description
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
Time Frame
Baseline until disease progression or death
Title
Time to response as assessed by the IRF
Description
From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first
Time Frame
Baseline until the initial occurrence of CR or PR
Title
Complete response (CR) rate as assessed by the IRF and the investigator
Description
Percentage of patients with CR for target lesions after BNCT
Time Frame
Baseline until the initial occurrence of CR
Title
Disease control rate as assessed by the IRF and the investigator
Description
Percentage of patients with CR, PR and SD for target lesions after BNCT
Time Frame
Baseline until the initial occurrence of CR, PR or SD
Title
Overall response rate as assessed by the IRF and the investigator
Description
Percentage of patients with CR or PR after BNCT
Time Frame
Baseline until the initial occurrence of CR or PR
Title
Locoregional progression-free survival as assessed by the investigator
Description
From the date of BNCT until confirmed in-field disease progression
Time Frame
Baseline until in-field disease progression
Title
Extra-regional relapse-free survival as assessed by the investigator
Description
From the date of BNCT until confirmed extra-field disease progression (new lesions)
Time Frame
Baseline until extra-field disease progression
Title
Progression-free survival as assessed by the IRF and the investigator
Description
From the date of BNCT until confirmed disease progression or death, whichever occurred first
Time Frame
Baseline until disease progression or death
Title
Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator
Description
Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT
Time Frame
Baseline until Day90
Title
Overall survival
Description
From the date of BNCT until death from any causes
Time Frame
Baseline until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Measurable disease, as defined by RECIST v1.1.
Exclusion Criteria:
Apparent disseminated tumor lesions.
Hereditary fructose intolerance.
Phenylketonuria.
Any serious concomitant disease that precludes completion of the study treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toshimitsu Hayashi
Phone
+81-06-4707-1516
Email
sp-chiken@stella-pharma.co.jp
Facility Information:
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
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