Malignant Solid TumourNCT01151930
Long-Term Compassionate Use Study for Continued Administration of SCB01A-01
A study testing SCB01A in people with Malignant Solid Tumour, run by SynCore Biotechnology Co., Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour
- What is being tested?
- SCB01A
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Malignant Solid Tumour
- Being tested
- SCB01A
- Keywords
- Advanced solid tumor failed with standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB01ADrug
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- SynCore Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151930
- Sponsor's protocol ID
- SCB01A-01-B
- Status last verified
- Oct 2017
- First submitted
- 23 Jun 2010
- Last updated
- 17 Nov 2020
- Results posted
- No
Publications
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.
PubMed 33245172
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01151930
- Acronym / sponsor ID
- SCB01A-01-B
- Conditions
- Malignant Solid Tumour
- Keywords
- Advanced solid tumor failed with standard therapy
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- SynCore Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCB01AThis 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 33245172Shiah 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.
Related trials for Malignant Solid Tumour
Active, not recruitingEarly Phase 1
Analysis of Whole Body Magnetic Resonance Imaging and Liquid Biopsy for Early Detection of Cancer in Patients With a Strong Family History of Cancer
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing AZD1775 as a Potential Targeted Treatment in Cancers With BRCA Genetic Changes (MATCH-Subprotocol Z1I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
Malignant Solid Tumor
Not yet recruitingObservational study
Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SCB01A in people with Malignant Solid Tumour, run by SynCore Biotechnology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.