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

NCT01151930 | Unknown

• 1 other identifier: SCB01A-01-B
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Solid Tumour

Keywords

Advanced solid tumor failed with standard therapy

Interventions

SCB01A DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Study participants meeting any of the following criteria will be excluded from enrollment:
• Unwilling or unable to provide informed consent.
• Unwilling or unable to comply with the requirements of the protocol.
• Has unresolved toxicities from previous SCB01A-01 protocol.

Sponsors & Collaborators

• SynCore Biotechnology Co., Ltd.: lead

Related Publications (1)

• Shiah HS, Chiang NJ, Lin CC, Yen CJ, Tsai HJ, Wu SY, Su WC, Chang KY, Wang CC, Chang JY, Chen LT. Phase I Dose-Escalation Study of SCB01A, a Microtubule Inhibitor with Vascular Disrupting Activity, in Patients with Advanced Solid Tumors. Oncologist. 2021 Apr;26(4):e567-e579. doi: 10.1002/onco.13612. Epub 2020 Dec 18.

  PMID: 33245172 DERIVED

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 29, 2010
• Last Updated: November 17, 2020

Record last verified: 2017-10