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NCT01151930 Clinical Trial

Long-Term Compassionate Use Study for Continued Administration of SCB01A-01

Malignant Solid Tumour Clinical Trial

Official title:
Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A-01

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01151930
Other study ID # SCB01A-01-B
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date October 2017
Source SynCore Biotechnology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.

Description:

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SCB01A
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 2 cycles of treatment under the SCB01A-01 protocol.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
SynCore Biotechnology Co., Ltd.
See also
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