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

• Conditions: Malignant Solid Tumour

• Registration Number: NCT01151930
• Lead Sponsor: SynCore Biotechnology Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Status Verified: 2017-10
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified