Colorectal CancerPhase 2NCT01305980
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer
A Phase 2 study testing SB injection in people with Colorectal Cancer, run by SBPharmaceutical IND, Co., LTD at 1 site in South Korea.
Trial summary
The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SB injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Mar 2012
- Phase
- Phase 2
- 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
- Age of 18years or over
- Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions
- Life expectancy >/= 5 months
- Not available to any of resectable surgery or radiotherapy
- Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by
- Absolute neutrophil count >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L
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- Total bilirubin < 2.0 mg/dL
- Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal
- creatinine < 2 x Upper Limit Normal
- ECOG status 0 to 2
- Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago
- Patients or their legal representatives who have signed the informed consent form.
Who cannot join
- Have inflammatory bowel diseases
- Have severe diarrhea or ileus
- Previous total colectomy
- Have ileostomy
- Known brain or spinal cord metastases
- Patients who have received chemotherapy within the previous 4 weeks
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- Patients who have received radiotherapy related tp colorectal cancer within 4weeks
- Patients who have participated in other clinical study within the previous 4weeks
- Pregnancy or lactation period
- Human Immunodeficiency Virus antibody (+)
- Have active infection or serious concomitant systemic disorder incompatible with the study
- Clinically hypertension or diabetes mellitus not well controlled with medication
- Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
- Presence or history of malignancy other than colorectal cancer within 5years
- Have severe Neurologic or psychological disorder
- Patients who have history of allergy with this investigational drug(SB injection)
- Obvious cognitive or physical impairment that would prevent participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon, Jung-gu, 400-711
Yong-oon Shin, Prof., 032-890-2548, ywshin@inha.ac.kr
Ji-yeon Lee, RN/BSc, 032-890-1133, twinkleclara@inha.com
About this study
Official title: Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer
The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.
Read the detailed description
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy will be evaluated every 3 cycles.
- Conditions
- Colorectal Cancer
- Being tested
- SB injection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB injectionDrug
Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating Tumor Response Rate
Measured: 4 months
Secondary outcomes (3)
Pain Scores on the Visual Analog Scale
Measured: 4 months
evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale
Measured: 4 months
Determine duration of response rate by measuring time to progression
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SBPharmaceutical IND, Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yong-oon Shin, Prof, Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305980
- Sponsor's protocol ID
- SB injection-C002
- Status last verified
- Mar 2011
- First submitted
- 25 Feb 2011
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01305980
- Acronym / sponsor ID
- SB injection-C002
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SBPharmaceutical IND, Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 1 Mar 2011 (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 purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.
Detailed description
All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy will be evaluated every 3 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age of 18years or over
- Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions
- Life expectancy >/= 5 months
- Not available to any of resectable surgery or radiotherapy
- Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by
Key exclusion criteria (17 listed)
- Have inflammatory bowel diseases
- Have severe diarrhea or ileus
- Previous total colectomy
- Have ileostomy
- Known brain or spinal cord metastases
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 |
|---|---|---|
| SB injectionInfusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months | Drug | – |
Primary outcome
Evaluating Tumor Response Rate
Time frame: 4 months
3 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: 4 months
evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale
Time frame: 4 months
Determine duration of response rate by measuring time to progression
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2011.
- SBPLink provided by the sponsor.
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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.
Yong-oon Shin, Prof principal investigator
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB injection in people with Colorectal Cancer, run by SBPharmaceutical IND, Co., LTD at 1 site in South Korea.
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 12 inclusion and 17 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 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yong-oon Shin, Prof. (032-890-2548, ywshin@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating Tumor Response Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2011.