Non Small Cell Lung CancerPhase 2NCT01305967
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing SB injection in people with Non Small Cell Lung Cancer, run by SBPharmaceutical IND, Co., LTD at 3 sites in South Korea.
Trial summary
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- SB injection
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2003to Jun 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-70 years
- Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer
- Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
- Patients with measurable lesions
- Eatern Cooperative Oncolgy Group status 0 to 2.
- Life expectancy >/= 5 months
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- Patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by
- Absolute neutrophil count >/= 1.5 x 10^9/L, Platelet count >/= 100 x 10^9/L
- Total bilirubin </= upper limit of normal
- Aspartate Aminotransferase and/or Alanine Aminotransferase </= 2 x upeer limit of normal
- creatinine </= 1.5 x upeer limit of normal
- Patients who have signed the informed consent form.
Who cannot join
- Female volunteers admitted to the study must be using a reliable means of contraception
- Received radiation therapy within 6 weeks before randomization
- Known brain or spinal cord metastases
- Have acute infection
- Have active infection or serious concomitant systemic disorder incompatible with the study
- Presence or history of malignancy other than Non-Small Cell Lung Cancer
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- Have severe neurologic or psychological disorder
- Patients who have to receive other chemo-radiotherapy or immunotherapy
- Patients who have received chemotherapy within the previous 30 days
- Patients who are candidates for combined modality treatment.
- Patients who have participated in a clinical study within the previous 30 days
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 1 recruiting
- Recruiting
Sam Anyang Medical Center
Anyang, Man-an-gu, 430-733
Cae-young Lee, MD, 031-467-9188, joy@bovie.org
- Completed
Keimyung University Dongsan Hospital
Daegu, Jung-gu, 700-712
- Completed
Kyungpook University Hospital
Deagu, Jung-gu, 700-721
About this study
Official title: Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.
Read the detailed description
All eligible patients will receive SB injection therapy for 4 cycles (14~21 days for each cycle). SB injection treatment could be continue after completion of therapy cycles until 6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be evaluated every two cycles.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- SB injection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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, Intravenous route, 16times for 2.5 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Best Response Rate
Measured: 2.5 months
Secondary outcomes (3)
Determine duration of response rate by measuring time to progression
Measured: 2.5 months
Pain Scores on the Visual Analog Scale
Measured: 2.5months
Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale
Measured: 2.5months
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 startJan 2003
- Primary completionMay 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SBPharmaceutical IND, Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jae-yong Park, Professor, Principal investigator, Kyungpook University HospitalSeung-beom Han, Professor, Principal investigator, Keimyung University Dongsan Medical CenterChae-young Lee, Medical Doctor, Principal investigator, Anyang Sam Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305967
- Sponsor's protocol ID
- SB Injection
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱa,Open Label,Multicenter Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01305967
- Acronym / sponsor ID
- SB Injection
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SBPharmaceutical IND, Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- May 2011 (estimated)
- Study completion
- Jun 2011 (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 Non Small Cell Lung Cancer.
Detailed description
All eligible patients will receive SB injection therapy for 4 cycles (14~21 days for each cycle). SB injection treatment could be continue after completion of therapy cycles until 6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be evaluated every two cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age of 18-70 years
- Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer
- Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
- Patients with measurable lesions
- Eatern Cooperative Oncolgy Group status 0 to 2.
Key exclusion criteria (11 listed)
- Female volunteers admitted to the study must be using a reliable means of contraception
- Received radiation therapy within 6 weeks before randomization
- Known brain or spinal cord metastases
- Have acute infection
- Have active infection or serious concomitant systemic disorder incompatible with the study
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, Intravenous route, 16times for 2.5 months | Drug | – |
Primary outcome
Overall Best Response Rate
Time frame: 2.5 months
3 secondary outcomes
Determine duration of response rate by measuring time to progression
Time frame: 2.5 months
Pain Scores on the Visual Analog Scale
Time frame: 2.5months
Evalute patient's performance by measuring the Eastern Cooperative Oncology Group scale
Time frame: 2.5months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Jae-yong Park, Professor principal investigator
Kyungpook University Hospital
Seung-beom Han, Professor principal investigator
Keimyung University Dongsan Medical Center
Chae-young Lee, Medical Doctor principal investigator
Anyang Sam Medical Center
3 sites 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 Non Small Cell Lung Cancer, run by SBPharmaceutical IND, Co., LTD at 3 sites 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 11 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 1 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 3 sites 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 Chae-young Lee, Medical Doctor (031-467-9188, joy@bovie.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Best Response Rate (time frame: 2.5 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 1 Mar 2011.