Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A -01
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Malignant Solid Tumour
Both
Malignant Solid Tumour
Trial Information
Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A -01
This is a companion study to the protocol SCB01A-01 intended to provide long-term continued
administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is
an open-label, single-arm study of SCB01A in subjects who have completed at least one cycles
of treatment under the SCB01A-01 protocol.
Inclusion Criteria:
Subjects who completed protocol SCB01A-01 and exhibited a favorable response or had no
clinical evidence of disease progression (i.e. stable disease, partial response or
complete response).
Exclusion Criteria:
Study participants meeting any of the following criteria will be excluded from enrollment:
1. Unwilling or unable to provide informed consent.
2. Unwilling or unable to comply with the requirements of the protocol.
3. Has unresolved toxicities from previous SCB01A-01 protocol.
Type of Study:
Expanded Access
Study Design:
N/A
Authority:
United States: Food and Drug Administration
Study ID:
SCB01A-01-B
NCT ID:
NCT01151930
Start Date:
September 2011
Completion Date:
September 2012
Related Keywords:
- Malignant Solid Tumour
- Advanced solid tumor failed with standard therapy
- Neoplasms
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